Clinical Trials
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Diabetes and Endocrinology
A Multicenter Phase II Pilot Open Label (BKM120)
Apr 2013Due to the high frequency of activation of PI3K and downstream effectors in progressive, recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic target and should be properly evaluated in advanced follicular and poorly differentiated thyroid carcinomas
Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)
Apr 2013This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated four weeks after end of treatment. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.
A Multicenter Phase II Pilot Open Label (BKM120)
Apr 2013Due to the high frequency of activation of PI3K and downstream effectors in progressive, recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic target and should be properly evaluated in advanced follicular and poorly differentiated thyroid carcinomas
Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)
Apr 2013This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated four weeks after end of treatment. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.
Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes1
Mar 2013The purpose of this study is to evaluate the effect of DPP-IV inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12 months after randomization.
Effects of metformin on hepatic free fatty acid metabolism in type 2 diabetes asssessed by positron emission tomography
Mar 2013It is the general purpose of the trial to investigate whether the positive effects of metformin on blood lipids are caused by improved glycemic control and changes in body composition or if they are caused by direct effects on lipid metabolism. We specifically plan to: - investigate hepatic fatty acid uptake, reesterification and oxidation assessed by positron emission tomography (PET) - investigate the effect of metformin on whole body VLDL-TG oxidation and redeposition in adipose tissue.
GLP-1 Receptor Targeting in Diabetic and Healthy Individuals (GLP-1-CPOP)
Mar 2013The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.
A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®)
Mar 2013This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c).
Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management (AIRPEDIA)
Mar 2013The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.
Acute Exercise and Pancreatic Endocrine Function
Mar 2013Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.
Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes
Mar 2013The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2 diabetic patients who had two 24 hour measurements performed within one week with the Arteriograph24 equipment.
Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma
Mar 2013The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration.
Effects of oral chronic administration of ivabradine (7.5 mg bid) in comparison to placebo (bid) on top of beta-blockers, on central aortic blood pressure. Randomized, cross-over, double blind, multicentre, study over 10 weeks in patients with stable coronary artery disease, type II diabetes and a resting heart rate equal or superior to 70 bpm, already treated with beta-blockers.
Mar 2013To evaluate the effect of ivabradine on central aortic systolic blood pressure (CASBP) in comparison to placebo in patients with stable CAD, type II diabetes, and a resting HR≥ 70 bpm, treated by beta-blockers.
Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation (REP0211)
Mar 2013The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantion. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. Thus, the use of reparixin may emerge as a potential key component in the sequentially integrated approach to immunomodulation and control of non specific inflammatory events surrounding the early phases of pancreatic islet transplantation in type 1 diabetes (T1D) patients.
Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)
Mar 2013The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic cancer disease by combining the new investigational medicinal product Atu027 with the standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s anti-tumor activity with Atu027. The objectives of this clinical trial are to evaluate safety and activity of two Atu027 schedules in combination with standard gemcitabine treatment in patients with advanced or metastatic pancreatic adenocarcinoma.
A Randomized, Multicenter Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes
Feb 2013The primary objective of Study 107 is to obtain CV event data that will be pooled with CV event data from other pivotal Phase 3 studies in a meta-analysis to demonstrate that the upper limit of the 95% confidence interval of the hazard ratio of major adverse cardiac events (MACE) in adult patients on Standard of Care for T2D receiving either ITCA 650 or control, based on the time to first occurrence of any event in the MACE1 CV composite endpoint (CV death, non-fatal myocardial infarction [MI], non-fatal stroke, or hospitalization for unstable angina), does not exceed 1.8.
A prospective, open, randomized, academic phase II, two-arm trial evaluating the effect of fibrin-coated collagen (TachoSil®) on postoperative pancreatic leakage and fistula formation from the pancreato-enteric anastomosis in patients undergoing partial pancreaticoduodenectomy
Feb 2013To demonstrate that fibrin-coated collagen patch (TachoSil) significantly decreases postoperative pancreatic leakage and prevents pancreatic fistula formation in patients undergoing partial pancreatico-duodenectomy with pancreato-enteric anastomosis
A Comparison of LY2605541 versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with 2 or more Oral Antihyperglycemic Medications: An Open-Label, Randomized Study.
Feb 2013To demonstrate that LY2605541 (pooled before morning meal [AM] administration and at bedtime [PM] administration) is noninferior to human insulin NPH for change in hemoglobin A1c (HbA1c) from baseline to 26 weeks
Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial
Feb 2013The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.
Nintedanib(BIBF1120) in Thyroid Cancer
Feb 2013Angiogenesis pathway represents a set of potential targets for targeted therapies in thyroid cancer. VEGF receptors (VEGFR) and especially VEGFR-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. Vascular endothelial growth factor (VEGF) and VEGF receptors (VEGFR-1, VEGFR-2) as well as receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed in thyroid cancer. These receptors are also expressed on perivascular cells, such as pericytes and smooth muscle cells, that are also involved in tumor angiogenesis. Tyrosine kinase inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. Vandetanib is approved for MTC and it is expected soon that sorafenib will be approved for differentiated thyroid cancer. The treatment options for patients with DTC and MTC who have progressed on one line of therapy are limited and there is no treatment that is generally considered as standard of care. No clinically meaningful benefit has yet been demonstrated with cytotoxic chemotherapy. On the other hand patients are still in good general condition and may still benefit from treatment and experience survival prolongation. Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF therefore acting potentially not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of its multi-kinase activity rationale exists to develop it in both MTC and DTC. By targeting these three major angiogenesis signaling pathways it is believed that nintedanib can prevent further tumor growth and related tumor escape mechanisms. This also means that nintedanib may be active in patients who have progressed on agents that target only one pathway.
Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay
Feb 2013The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.
The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA (IN CONTROL)
Feb 2013The purpose of this study is to determine what the effects are of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired hypoglycemia awareness.
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
Feb 2013After 24 weeks, to assess the effect of the addition of treatment with MK- 3102 compared to placebo on A1C. To assess the safety and tolerability of MK-3102.
Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
Feb 2013Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control. As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.
An Observational Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Jan 2013This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with Tarceva (erlotinib) plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.
Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity
Jan 2013Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.
Closing the Loop in Children and Adolescents With Type 1 Diabetes in the Home Setting (APCam08)
Jan 2013Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong insulin therapy. Children and adolescents with T1D need regular insulin injections or the continuous insulin delivery using an insulin pump in order to keep blood glucose levels normal. We know that keeping blood sugars in the normal range will help prevent longterm diabetes-related complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk to develop symptoms and signs of low glucose levels (hypoglycaemia). This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is controlled by a computer and is very closely matched to the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed-loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. We have been testing such a system in Cambridge over the last five years in children and have found that this system is effective at maintaining tight glucose control and preventing nocturnal hypoglycaemia. More recently the system has been tested in real life conditions in the home setting for three weeks during a pilot single-centre study. The next step is to extend the evaluation of closed-loop over a prolonged period of three months. In the present study we are planning to study 24 young people aged 6-18 years on insulin pump therapy. During three months glucose will be controlled by the computer and during the other three months the subjects will make their own adjustments to the insulin therapy. We aim to to determine the effect of the computer algorithm in keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and reducing the time they spent with glucose below 3.9 mmol/L (hypoglycaemia). Participants' response to the use of the system in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be assessed. We will also test for longer term glucose control by measuring glycated haemoglobin (HbA1c).
Study of LY3016859 in Participants With Diabetic Nephropathy
Jan 2013The purpose of this two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria.
National Anaplastic Thyroid Cancer Tissue Bank and Database (NATT)
Jan 2013The primary objective of this project is to establish a national anaplastic thyroid cancer tissue collection to help facilitate both basic and translational research opportunities.
Environmental Chemicals and Their Role in Obesity (ENDORUP)
Jan 2013Hormonal disruption is the inappropriate alteration of the hormonal system by chemical substances that are present in our environment. Some chemical substances are capable of replicating, enhancing or reducing the production, release, transport or action of natural hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic' endocrine disrupters such as pesticides and dioxins are considered responsible for infertility, cancer and thyroid problems. Recently, a number of additional chemical substances were stipulated to have endocrine disrupting capabilities. The industrial production of these substances in large quantities has led to an accumulation in our environment and thus possible negative consequences on human health. The aim of this study is to investigate the rol of these chemical substances in the occurence of overweight and obesity.
Closed-loop Insulin Delivery in the General Ward (ANGIE02)
Jan 2013The main study objective is to compare conventional insulin therapy with automated closed-loop glucose control over 72 hours in achieving target glucose levels in hospitalised insulin-treated Type 2 diabetes (T2D) subjects. This is an open-label, two-arm, randomised, parallel design study in hospitalised insulin-treated T2D subjects, during which target glucose levels will be controlled either by closed-loop system combined with real-time continuous subcutaneous glucose monitoring (CGM) or by conventional insulin therapy.
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Jan 2013This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
An open, single-centre, non-controlled feasibility study using a softwarealgorithm based insulin therapy to control blood glucose in type 1 diabetic patients
Jan 2013To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients. (Pascal)
Jan 2013The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.
A Phase III, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects with Type 2 Diabetes Mellitus with Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control
Jan 2013After 24 weeks, to assess the safety (incidence of adverse events) and tolerability (discontinuation rate) of MK-3102. After 54 weeks, to assess the safety (incidence of adverse events) and tolerability (discontinuation rate) of MK-3102.
Protocol H9X-MC-GBDG A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Patients with Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 8)
Jan 2013The primary objective of this study is to demonstrate that once-weekly dulaglutide 1.5 mg is superior to placebo as measured by glycosylated hemoglobin A1c (HbA1c) at 24 weeks (change from baseline) in patients with type 2 diabetes mellitus on concomitant sulfonylurea therapy
REVISE-Diabesity: Randomisation to Endoluminal intestinal liner alone Versus with Incretin analogue in SustainEd Diabesity
Jan 2013In an NHS setting, what is the impact of Endobarrier (a device inserted into the intestine to coat its inside and prevent absorption of food where it is sited) alone versus combined Endobarrier-Liraglutide therapy (a daily injectable medication for type 2 diabetes) in patients with obesity and type 2 diabetes mellitus who have not yet met national treatment targets despite at least 6 months of Liraglutide treatment alone?
Treatment of antipsychotic associated obesity with a GLP-1 Analogue: the TAO study
Jan 2013To investigate if 3 months treatment with a GLP-1-analogue can reduce antipsychotic associated obesity in non-diabetic patients with a diagnosis within the schizophrenic spectrum
Spectroscopy From Duodenum
Dec 2012Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.
Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma (MAESTRO)
Dec 2012This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled.
Treat-To-Target Trial of Continuous Subcutaneous , sensor-augmented insulin-pump therapy in new-onset diabetes after transplantation (SAPT-NODAT): Efficacy and Safety of an Intensive Insulin Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based Immunosuppression
Dec 2012To demonstrate superiority of continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation, and aiming for a pre-supper target capillary blood glucose level of 110 mg/dL against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c at 3 months post-transplantation (comparison will be made against the simultaneously monitored control group of the ITP-NODAT study [=arm B])
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus
Nov 2012To assess the impact of MK-3102 25 mg q.w. on time to confirmed CV outcomes across the MK-3102 program To assess the safety and tolerability of MK-3102 25 mg q.w.
A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients with Type 2 Diabetes
Nov 2012Demonstrate that ITCA 650 is non-inferior to sitagliptin in reducing HbA1c in patients with type 2 diabetes following 52 weeks of treatment. The non-inferiority margin is 0.3%. If non-inferiority is demonstrated, then ITCA 650 will be tested for superiority in reducing HbA1c
TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors (68-DOTANOC-GEP)
Nov 2012Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy). Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.
ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)
Nov 2012The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion
A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma (PACT-19)
Nov 2012The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the feasibility and the activity of the PAXG regimen in patients with stage III and IV pancreatic cancer.
A Phase II/III, Multi-center, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer
Oct 2012The primary objective of the study is to compare overall survival in chemotherapy-naive patients with metastatic pancreatic cancer receiving gemcitabine 1000 mg/m2 weekly combined with ON 01910.Na at 1800 mg/m2 via 2-hour continuous intravenous infusions administered twice weekly for 3 weeks of a 4-week cycle vs. gemcitabine alone at 1000 mg/m2 weekly for 3 weeks of a 4-week cycle.
Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma (SUMMIT)
Oct 2012The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.
A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
Oct 2012After 54 weeks, to assess the A1C-lowering efficacy of MK-3102 compared to glimepiride. To assess the safety and tolerability of MK-3102.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy with Dapagliflozin added to Saxagliptin in Combination with Metformin compared to Therapy with Placebo added to Saxagliptin in Combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin Pharmacogenetics Blood Sample Amendment 01 - Site Specific, (V1.0, dated 22-June-2012)
Oct 2012The purpose of this study is to learn if BMS-512148 (dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy with Saxagliptin and Dapagliflozin added to Metformin compared to Add-On Therapy with Saxagliptin in combination with Metformin or Dapagliflozin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone
Oct 2012To compare the mean change from baseline in glycosylated hemoglobin (HbA1c) achieved with concurrent addition of saxagliptin and dapagliflozin to metformin versus the addition of placebo & saxagliptin to metformin & versus the addition of placebo plus dapagliflozin to metformin after 24 weeks of double-blind treatment.
I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer (CLERAD-PROBE)
Oct 2012This study is designed to compare effectiveness of treatments following and evaluating guideline recommendations in two assignment arms.
The Most Effective Treatment Strategy for Diabetic Macular Edema.
Sep 2012To evaluate whether laser photocoagulation prolongs treatment effect of anti-VEGF for DME.
A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas
Aug 2012To assess the potential for interference of Gemcitabine on immune response to TG01 as determined by TG01 specific DTH skin test reaction and T-cell function in peripheral blood in patients receiving TG01 and GM-CSF after primary resection of pancreatic adenocarcinoma
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with Non-Insulin Antihyperglycemic Drugs with a 6-month Safety Extension Period
Aug 2012To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6, week 26) in patients with type 2 diabetes mellitus.
Safety, Tolerability and Effectiveness of Glocophage®SR in patients with type-2 Diabetes and Chronic Kidney Disease (eGFR 30 to 45mL/minute/1.73m2)
Aug 20121% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo.
A multicenter, two stage, phase II study, evaluating the efficacy of oral BEZ235 plus best supportive care (BSC) versus placebo plus BSC in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy
Aug 2012To estimate the efficacy of BEZ235 in adult patients with advanced (unresectable or metastatic) pNET (PFS)
Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors
Aug 2012To assess the treatment effect of BEZ235 relative to everolimus on progression free survival in patients with advanced pancreatic neuroendocrine tumors who have not been previously treated with an mTOR inhibitor.
A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation.
Aug 2012The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in T1D patients. The safety of reparixin in the specific clinical setting will be also evaluated.
A prospective randomized phase II trial of FOLFIRINOX, and radiation therapy versus FOLFIRINOX alone in patients with locally advanced pancreatic cancer that cannot be removed by surgery
Jul 2012R0 resection rate
A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Glimepiride When Used in Combination with Metformin in Subjects with Type 2 Diabetes
Jul 2012To evaluate the efficacy of TAK-875 plus metformin compared to glimepiride plus metformin on glycemic control as assessed by change from baseline in HbA1c at Weeks 78 and 104.
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination with Metformin in Subjects with Type 2 Diabetes
Jul 2012To evaluate the efficacy of TAK-875 plus metformin compared to placebo plus metformin and sitagliptin plus metformin on glycemic control as measured by change from baseline in HbA1c over a 24-week Treatment Period.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events
Jul 2012The primary objective is to demonstrate that no excess risk of CV composite events exists following treatment with TAK-875 compared with placebo when given in combination with Standard of Care in subjects with T2DM and clinically evident CV disease or multiple risk factors for CV events. For purposes of this study, the primary MACE composite comprises CV death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).
The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification
Jul 2012To confirm the efficacy of IDeg compared to placebo, both in combination with liraglutide and metformin, in controlling glycaemia
Treatment with Liraglutide in type 1 diabetic patients. Effects on glycemic control and counterregulation and cognitive performance during hypoglycaemia.
Jul 2012Part 1: To investigate how long-term treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide or placebo, respectively, affects counterregulatory hormones and cognitive performance during hypoglycemia.
Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)
Jul 2012In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.
The influence of liraglutide on hypoglycaemia counterregulation and pulsatile insulin secretion in type 2 diabetics
Jun 2012To establish, whether liraglutide improves the glucagon concentration under hypoglycaemic conditions in patients with type 2 diabetes
A Phase 2, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Peripheral Neuropathy
Jun 2012To assess the efficacy of GRC 17536 in the treatment of pain associated with diabetic peripheral neuropathy (DPN).
A randomised, double blind, placebo controlled, parallel group efficacy and safety study of oral administration of empagliflozin twice daily versus once daily in two different daily doses over 16 weeks as add-on therapy to a twice daily dosing regimen of metformin in patients with type 2 diabetes mellitus and insufficient glycaemic control
Jun 2012To investigate the efficacy and safety of different dosage regimens of empagliflozin, 5mg twice daily compared to 10 mg once daily versus placebo and 12.5 mg twice daily compared to 25 mg once daily versus placebo, administered orally as add-on therapy to metformin in patients with T2DM and insufficient glycaemic control
Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Jun 2012Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study.
Clinical proof-of-principle of the determination of the beta cell mass in vivo by SPECT imaging with the 111In-labeled GLP-1 analogue DTPA-[K40]-Exendin 4
Jun 2012The primary objective is to proof that the pancreatic uptake of EX in patients with long-standing DM1 and non-measurable production of C-peptide, i.e. patients with no relevant beta-cell mass left, is clearly lower than in healthy individuals with intact glucose homeostasis and insulin production.
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Jun 2012The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.
Jun 2012To determine the effect of linagliptin compared to placebo on basal production and release of nitric oxide (NO) from renal vasculature, as assessed by changes of renal plasma flow due to L-NMMA infusion.
Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes
May 2012To confirm the superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg, 1.8 mg) in combination with metformin in controlling glycaemia versus metformin and liraglutide placebo in children and adolescent (ages 10–17 years) with type 2 diabetes.
A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of Aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin monotherapy.
May 2012To evaluate if aleglitazar improves cardiac energetics, by means of MRS, in uncomplicated T2D patients with no history of CAD, after 6 weeks of treatment
The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy
May 2012To confirm superiority of insulin degludec/liraglutide compared to insulin degludec/liraglutide placebo in controlling glycaemia as add-on treatment in insulin naïve subjects with Type 2 Diabetes Mellitus (T2DM) inadequately controlled on sulphonylurea (SU) with or without metformin therapy after 26 weeks of treatment.
FTO-genotype dependent weight reduction under treatment with bromocriptin in obese patients
May 2012Reduction of BMI
A phase Ib/II open-label, multi-center study of the combination of MEK162 plus AMG 479 (ganitumab) in adult patients with selected advanced solid tumors
May 2012Phase Ib: Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) by measuring incidence of dose limiting toxicities Phase II: Antitumor activity of MEK162 in combination with AMG 479 by evaluating Objective Response Rate (ORR) in colorectal carcinoma and melanoma and by evaluating Disease Control Rate (DCR) at week 10 in pancreatic carcinoma
The effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathy
Apr 2012To assess the change in tear film thickness in eyes with thyroid-associated ophthalmopathy treated with intravenous glucocorticoids
A randomized open-label study to compare safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy
Apr 20121. To demonstrate that add-on to glimeperide vildagliptin is superior to NPH insulin with respect to the incidence of the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) and weight gain (+3%) in T2DM patients. 2. To demonstrate that add-on to glimepiride vildagliptin is superior to NPH insulin with respect to the rate of of confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) in T2DM patients.
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
Apr 2012To assess the objective response rates (ORR) for 150 mg and 300 mg/day of vandetanib in patients with advanced & progressive MTC. ORR = % of patients with a best response of complete or partial response (CR/PR) as per RECIST Version1.1
Diagnosing Thyroid Cancer Using a Blood Test
Apr 2012Thyroid cancer is a relatively rare disease but its incidence is increasing in many countries.. Early and accurate diagnosis leading to earlier treatment and intervention is recognised as a major factor in determining a good outcomes. This study will investigate new ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. The study will take samples from patients with differentiated thyroid cancer and measure relative quantities of 1000s of proteins within the blood. These measures will be explored to see if, when used in combination they can accurately diagnose thyroid cancer. If successful this technique could be extended to routine screening and could replace more invasive tests currently used. Participants will be required to supply a small sample of blood, answer questions on their medical history and also consent for their medical records to be examined. A lifestyle questionnaire will also be supplied to each participant. In the case where a diagnosis is predicted for a condition the participant was not aware of the medical team will discuss the best interests of the patient with their GP and if required refer them to a suitable specialist. The study will run for 24 months and will routinely process around 15 and 20 participants with a history of thyroid cancer per month. All patient details will be kept confidential and only non identifiable information will leave the clinic. The work will be published and if successful will be validated on another site, commercialised and made available for routine clinical use.
Pharmacokinetics of intravenous acetaminophen and its metabolites in morbidly obese patients
Apr 2012To study the pharmacokinetics of acetaminophen and metabolites in morbidly obese patients and compare with normal weight patients.
Phase II multicenter single-arm study evaluating the safety and efficacy of everolimus as a first-line treatment in newly-diagnosed patients with advanced GI neuroendocrine tumors.
Apr 2012To evaluate 15month progression-free survival rate (15month PFS rate) (according to RECIST 1.1) in newly-diagnosed patients with advanced or unresectable GI and pancreatic neuroendocrine tumors treated with everolimus as a first-line treatment.
An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with painful diabetic neuropathy.
Apr 2012The primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe painful diabetic neuropathy.
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors
Apr 2012This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.
NAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398 versus 5- Fluorouracil and Leucovorin in Patients with Metastatic Pancreatic Cancer
Mar 2012To compare overall survival following treatment with MM-398 versus 5-fluorouracil and leucovorin in patients with metastatic pancreatic cancer that have progressed on gemcitabine based therapy.
A randomized, double-blind, placebo controlled trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of lixisenatide in paediatric (10 - 17 years old) and adult patients with type 2 diabetes
Mar 2012To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls
Randomized double-blind placebo controlled Phase II study to evaluate the efficacy and safety of Sorafenib treatment in patients with advanced (recurrent, persistent and/or metastasizing) medullary thyroid carcinoma (SUMMIT).
Mar 2012The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC
A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)
Mar 2012The primary objective in the Phase I portion is to assess the safety and tolerability of cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts.
Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
Mar 2012To study the activity of Vandetanib in children and adolescents with MEN-related MTC by measuring the change in tumor size, in blood levels of proteins produced the tumor (calcitonin and CEA) and in tumor-related diarrhea. To determine the safety and tolerability of Vandetanib in children and adolescents. To study how the body handles Vandetanib in children and adolescents. To determine the effect of Vandetanib on the survival of children and adolescents with MTC.
A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients with Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy
Mar 2012To determine if LY2495655 administered in combination with chemotherapy improves overall survival (OS), compared to chemotherapy in combination with placebo in patients with Stage II-IV unresectable pancreatic cancer
Effects of morning vs evening dosing on the pharmacokinetics and pharmacodynamics of sunitinib.
Mar 2012To determine the influence of morning versus evening administration on the pharmacokinetics of sunitinib and its metabolite
Study to evaluate the pharmacokinetic of vitamin D (cholecalciferol) in patients with obesity after bariatric surgery in vitamin D deficiency and after normalization
Mar 2012Establish vitamin D supplementation in obese patients after bariatric surgery.
A 24 week randomised, open label, 3 parallel-group comparison of once and twice daily biphasic insulin aspart (BIAsp) 30 plus sitagliptin and twice daily BIAsp 30, all in combination with metformin in insulin naïve type 2 diabetic subjects inadequately controlled on sitagliptin and metformin
Mar 2012To compare the efficacy in terms of glycaemic control of biphasic insulin aspart 30 (BIAsp 30) twice daily + sitagliptin + metformin, BIAsp 30 twice daily + metformin and BIAsp 30 once daily + sitagliptin + metformin in subjects with type 2 diabetes inadequately controlled on sitagliptin and metformin (± other oral anti-diabetic drugs (OADs))
Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy (FOThyr)
Feb 2012The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).
A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects
Feb 2012To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjects
Efficacy and safety of liraglutide versus placebo as add-on to existing diabetes medication in subjects with type 2 diabetes and moderate renal impairment
Feb 2012To confirm the superiority of liraglutide versus placebo as add-on to existing oral antidiabetic drug (OAD) and/or insulin therapy on glycaemic control after 26 weeks treatment in subjects with type 2 diabetes and moderate renal impairment
Insulin therapy in non-diabetic adults with cystic fibrosis
Feb 2012This study aims to investigate the effect of low dose insulin therapy on nutritional status en body weight.
Randomised, Multicenter Phase III Clinical Study of Lipoplatin plus Gemcitabine Versus Gemcitabine as First-Line Treatment in Inoperable, Locally Advanced or Metastatic Pancreatic Cancer
Feb 2012To compare the activity and safety between the two arms of treatment.
A 24-week, open-label, randomized, 2-arm parallel group, multinational, multi-center clinical trial to compare the efficacy and safety of lixisenatide injected prior to the main meal of the day versus lixisenatide injected prior to breakfast in type 2 diabetic patients not adequately controlled on metformin
Jan 2012To compare the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24)
a single arm open label international multi center study of the efficacy and safety of sunitinib malate (su011248, sutent®) in patients with progressive advanced metastatic well differentiated unresectable pancreatic neuroendocrine tumors.
Jan 2012To confirm sunitinib treatment effect on progression-free survival (PFS) per investigator assessment in subjects with advanced/metastatic, well differentiated, unresectable, pancreatic neuroendocrine tumors per RECIST.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared with Placebo in Subjects with Type 2 Diabetes
Jan 2012To evaluate the efficacy of TAK-875 compared with placebo on glycemic control as assessed by change from baseline in HbA1c over a 24-week Treatment Period.
Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes
Jan 2012The main objective of the trial is to investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy a) improves betacell function b) improves left ventricular ejection fraction (LVEF) during stress test in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD)
Phase II Study for the Evaluation of the Efficacy of Gemcitabine plus Erlotinib in Rash-positive Patients with metastatic pancreatic cancer and good risk factors
Jan 20121-year survival rate of "good risk" patients who develop Rash under treatment with gemcitabine/erlotinib
Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Dec 2011The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study.
Dec 2011To evaluate the analgesic efficacy of pregabalin in pancreatic cancer induced abdominal pain
A phase IIa study to characterize the effects of CCL2 inhibition with the Spiegelmer® NOX-E36 in patients with type 2 diabetes mellitus and albuminuria.
Dec 2011To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria
A Phase III, Multicenter, Double-Blind, Randomized, Placebo- and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control
Oct 2011In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control: (1) after 16 weeks, to assess the effect of treatment with sitagliptin compared with placebo on A1C (2) to assess the safety and tolerability of sitagliptin
A feasibility study of Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia – the pre-MENAC study
Oct 2011Is a multimodal intervention for cancer cacheixa feasible? Specific indiviudal treatments such as exercise, nutritional advice, dietary supplements and anti-inflammatory medications have been shown to be beneficial in isolation in the treatment of cancer cachexia. It is hypothesized that combining all of these as a "multimodal intervention" may be beneficial. Before a definitive study is conducted to assess this, it is important that the feasibility of delivering such an intervention is assessed - which is the purpose of the proposed study. The feasibility will be assessed by: Enrolment rate, Compliance with study intervention, study procedures and data collection, Contamination-rate in the control group with respect to any of the interventions in the intervention group, and Provide an estimate of the sample size required in futures studies in cachexia.
Phase II trial of individualized selection of chemotherapy in patients with advanced pancreatic carcinoma based on the identification of therapeutic targets in tumor tissue
Sep 2011Determination of the percentage of alive patients after 12 months since the beginning of the trial, in patients with advanced pancreatic carcinoma individually selected and grouped according to tumor tissue expression of therapeutic targets / Determinación de la proporción de pacientes vivos tras 12 meses del inicio del ensayo en enfermos con carcinoma de páncreas avanzado seleccionados de forma individualizada y agrupados en función de la expresión en tejido tumoral de Dianas Terapéuticas.
Phase II trial of individualized selection of chemotherapy in patients with advanced pancreatic carcinoma based on the identification of therapeutic targets in tumor tissue
Sep 2011Determination of the percentage of alive patients after 12 months since the beginning of the trial, in patients with advanced pancreatic carcinoma individually selected and grouped according to tumor tissue expression of therapeutic targets.
A Phase 1b/2 Study with Gemcitabine and LY2157299 for Patients with Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)
Aug 2011Phase 1b: To determine a safe/tolerable Phase 2 dose of LY2157299 for combination with gemcitabine in patients with solid malignancy, who failed previous approved therapies and/or are amenable to gemcitabine therapy (eg, pancreatic cancer, biliary tract, sarcoma). Phase 2: To compare overall survival (OS) in patients with Stage II-IV unresectable pancreatic cancer when treated with the combination of LY2157299 and gemcitabine with that of gemcitabine plus placebo.
Study Determining the Safety and Tolerability of Combination Therapy With Pazopanib and GSK1120212 in Advanced Solid Tumors Enriched With Patients With Advanced Differentiated Thyroid Cancer
Aug 2011The purpose of this study is to determine the safety and toxicity of the combination of pazopanib and GSK1120212 in patients with solid tumors and advanced thyroid cancer and identify the maximum tolerated dose (MTD) of this combination for phase II study.
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-month Safety Extension Period
Aug 2011Change in HbA1c from baseline to endpoint (scheduled month 6)
ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients
Jul 2011The principal research question for the phase III trial is to determine whether patient survival rates are no worse (non-inferior) for patients that do not receive Radioactive Iodine (RAI) ablation compared to those that do.
A Multicenter, Randomized, Double- Blind, Placebo-Controlled, Phase 3 Trial of E7080 in 131I- Refractory Differentiated Thyroid Cancer
Jul 2011To compare the progression-free survival of subjects with 131I-refractory differentiated thyroid cancer with radiographic evidence of disease progression within the prior 12 months treated with E7080 versus placebo.
An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents
Jul 2011The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention.
An open-label, multi-center, expanded access study of everolimus in patients with advanced neuroendocrine tumors
Jun 2011To evaluate additional safety of everolimus in patients with advanced neuroendocrine tumors of pancreatic origin.
A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease
Jun 2011The objective of this study is to perform a short-term study to assess how well tolerated combined recombinant growth hormone therapy (rhGH) and insulin-like growth factor (rhIGF-1) therapy is compared to rhGh alone in children/adolescents with Crohn's disease. i.e. will it be acceptable to a child to give two injections in the morning? It is hoped that the results from this phase II study will provide the scientific and safety data to allow us to apply for regulatory permission to move on to a Phase III study of long term growth in children/adolescents whose growth is affected by their inflammatory bowel disease.
Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
Jun 2011This is a pilot study which primary end point is evaluating the effect of Abraxane in combination with gemcitabine on tumor stroma, and the secondary end-point is correlating these changing with treatment activity.
A randomized, double-blind, placebo-controlled multi-center study of BYM338 for treatment of cachexia in patients with stage IV non-small cell lung cancer or stage III/IV adenocarcinoma of the pancreas
Jun 2011To assess the preliminary efficacy of a single intravenous dose of BYM338 in increasing thigh muscle volume as assessed by Magnetic Resonance Imaging compared to placebo.
Phase 2 Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects with Locally-advanced Pancreatic Cancer
May 2011The main objective of the trial is to compare overall survival (OS) of subjects with locallyadvanced pancreatic cancer (LAPC) who are randomized to receive dasatinib added to standard of care (gemcitabine [GEM]) versus standard of care (GEM) plus placebo
An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine
May 2011To evaluate best overall response rate (BORR) (complete + partial response) in Cohort 1 (sorafenib-naïve patients).
A randomized, open-label phase II multicenter study evaluating the efficacy of oral Everolimus alone or in combination with Pasireotide LAR i.m. in advanced progressive pancreatic neuroendocrine tumors (PNET)
Mar 2011To estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced PNET and to assess the predictive probability of success in a possible subsequent phase III study once 80 PFS events have been observed.
A Phase II Study of PM01183 as Second-line Treatment in Patients with Metastatic Pancreatic Cancer
Mar 2011To evaluate the antitumor activity of PM01183 in terms of overall survival rate at 6 months (OS6) in patients with metastatic pancreatic cancer.
A Randomized, International, Open-Label, Multi-Centre, Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients with Locally Advanced or Metastatic Medullary Thyroid Cancer Experience Grade 2 or Higher Adverse Events during the First 12 Months of Treatment with Vandetanib
Feb 2011To demonstrate a decrease in the percentage of time patients with locally advanced or metastatic medullary thyroid cancer experience AEs of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of a patient outreach programme
VIP: A prospective, phase II, double blinded, multicentre, randomised clinical trial comparing combination gemcitabine and vandetanib therapy with gemcitabine therapy alone in locally advanced or metastatic pancreatic carcinoma.
Feb 2011To assess whether overall survival time using gemcitabine plus vandetanib is longer than that using gemcitabine alone as the first treatment for advanced or metastatic pancreatic cancer.
A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer
Feb 2011No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by: Local and systemic toxicities, Number, type and degree of toxicities as measured by the NCI CTCAE v4.0, and QoL (EORTC QLQ-C30 supplemented with EORTC QLQ-PAN26).
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients with Diabetic Kidney Disease due to Type 1 or Type 2 Diabetes
Jan 2011Primary objective is to determine if LY2382770, administered monthly for 1 year is more effective than placebo at slowing the progression of diabetic kidney disease in patients treated with angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB)
Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer
Jan 2011The primary objective of this study is to compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.
A multi-center, phase I/II study of BAY 86-9766 in combination with gemcitabine in patients with locally advanced inoperable or metastatic pancreatic cancer
Dec 2010Phase I: Determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of BAY 86-9766 to be investigated in combination with the standard gemcitabine regimen in the subsequent Phase II part of this study
Internet Obesity Treatment Enhanced With Motivational Interviewing
Nov 2010The overall goal of this project is to determine if the addition of on-line Motivational Interviewing to a web-based group behavioral obesity treatment program will augment weight loss outcomes.
A Pan-European randomized, parallel group, two-arm placebo-controlled, double-blind multicenter study of Rimonabant 20mg once daily in the treatment of abdominally obese patients with impaired fasting blood glucose with or without other comorbidities
Oct 2010To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.
A Phase 2, Open-label, Proof-of-concept Study to Assess the Ability to Detect Tumours and Angiogenesis via the Expression of avb3 Integrin Receptors by [18F]AH111585 PET Imaging
Oct 2010To correlate the magnitude of [18F]AH111585 uptake and retention with quantitative measurement of the levels of avb3 integrin expression in tumours.
The Effects of Normalising Sex Hormone Levels in Obese Hypogonadal Men: A Prospective Randomized Comparator Controlled Parallel Arm Clinical Trial
Oct 2010The primary objective of the research project is to determine the effect of twelve weeks’ treatment with an aromatase inhibitor (Femara®, 2.5mg weekly) on the change in the serum concentration of the pro-inflammatory cytokine, C Reactive Protein, as measured by the Roche® Cobas immuno-turbidimetric test and compare it to that of twelve weeks’ treatment with a depot intramuscular formulation of testosterone undecanoate (Nebido®, 1g every 6 weeks) and to that of six weeks of no treatment.
Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)
Oct 2010The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population.
A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
Oct 2010After 12 weeks, to assess the effect of treatment with MK-3102 compared with placebo on A1C.
A pilot study on the effect of ARA290 on pain and pain responses and retinal edema in patients with diabetes mellitus and neuropathic pain
Jun 2010To study the effectiveness of ARA290 in the treatment of pain in neuropathic pain patients
Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer
Apr 2010Objectives: 1. To evaluate the natural history of FNMTC. 2. To determine the best screening strategy for FNMTC. 3. To identify genes that may indicate susceptibility to FNMTC.
Stool Testing for Pancreatic Cancer
Apr 2010The purpose of this study is to determine if pancreatic cancer/pre-cancer can be detected in early stages through the molecular analysis of stool samples. Investigators hypothesize that analysis of stool samples using digital melt curve (DMC)analysis, can be used as a sensitive and specific method to detect the common genetic abnormalities present in pancreatic cancers and pre-cancerous lesions of the pancreas.
Pancreatic Cancer Registry for High Risk Individuals
Apr 2010The aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer
A phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma
Mar 2010To compare the efficacy of CO-1.01 and gemcitabine in patients with metastatic pancreatic adenocarcinoma and low human equilibrative nucleoside transporter 1 (hENT1) expression
Sentinel Lymphnode in Patients With Papillary Thyroid Carcinoma and in Patients With Suspected Thyroid Neoplasia (SNTC)
Mar 2010The study investigates if the sentinel lymphnode (SN) : Reliably (with high sensitivity and specificity), can predict the pathological findings of the lymphnodes in the central compartment in patients with highly differentiated papillary thyroid cancer and Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear malignant potential, and could be used to select patients for further central lymphnode revision.
A Cancer Research UK Phase I/IIa Trial of an Oral Notch Inhibitor (MK-0752) in Combination with Gemcitabine in Patients with Stage IV Pancreatic Cancer
Mar 2010The trial is conducted in two phases and the objectives are: in phase I, to recommend a dose for further Phase II evaluation of MK- 0752 in combination with gemcitabine and to determine the safety and tolerability of MK-0752 in combination with gemcitabine in patients with Stage IV pancreatic cancer. In phase II, to measure survival at six months
Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer
Feb 2010In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care.
Chemoradiation with gemcitabine in combination with panitumumab for patients with locally advanced pancreatic cancer.
Feb 2010The main objective of the phase 1 part is to determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.
A multicentre double blind placebo controlled clinical dose- finding study for three doses of Antiadipositum X 112 T® (Cathine-hydrochloride) vs. placebo in 240 patients with a body mass index (BMI) between 27 kg/m2 and 40 kg/m2
Feb 2010Primary criterion is weight reduction in kilogram in the treatment groups (group 1- 3) compared with the placebo group (group 0) after 12 weeks
A phase II study to investigate the efficacy of RAD001 (Afinitor®, everolimus) in patients with irresectable recurrent or metastatic differentiated, undifferentiated (anaplastic) and medullary thyroid carcinoma
Jan 2010To determine the efficacy of RAD001 in patients with progressive irresectable recurrent or metastatic differentiated thyroid carcinoma
Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients (GDC)
Jan 2010The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes mellitus aged 18-69 years at inclusion into the study is to characterize in detail the clinical, metabolical and immunological phenotype and monitor the progression of the disease.
Effects of EXEnatide on Glycemic Control and Weight over 26 weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients with Type 2 Diabetes: a phase 2/3 doUble blind randoMized Placebo-controlled trial.
Jan 2010Change from baseline to 6 months of centrally measured HbA1c
A phase II, randomized, placebo controlled study to evaluate the efficacy of the combination of gemcitabine, erlotinib and metformin in patients with locally advanced and metastastatic pancreatic cancer
Jan 2010In this study we want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by the EGFR tyrosine kinase inhibitor erlotinb and metformin, combined with gemcitabine in patients with metatastatic pancreatic cancer.
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Dec 2009The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy and safety in previous studies; other studies are currently in progress. The results of previous studies indicate that teplizumab reduces the loss of insulin production during the first year after diagnosis in individuals with type 1 diabetes. The purpose of this study is to determine if teplizumab can interdict the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.
Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
Dec 2009The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer.
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children 10-16 With Chronic Kidney Disease (CKD).
Nov 2009Safety and efficacy study using Paricalcitol capsules to decrease parathyroid hormone levels in children ages 10-16 with Chronic Kidney Disease.
Does modulating the gut hormones, incretins, modify vascular function, thereby reducing the risk of vascular complications in insulin resistant individuals?
Nov 2009The overall aim of this research is determine whether increasing the levels of the gut hormones (incretins) by preventing their breakdown with the sugar lowering medication, Vildagliptin, improves 1) the function of both large and small blood vessels and 2) whether any observed improvements in blood vessel function translate to clinical benefits in the kidneys and the eyes in obese individuals.
Trial of LBH589 in Metastatic Thyroid Cancer
Oct 2009The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly.
Impact of an Integrated Obesity Management System on Patient's Care (ROGMF-2)
Oct 2009The investigators hypothesize that their program combining preceptorships with a virtual community will improve: (1) management and weight loss of obese/overweight subjects who are treated by PCPs for hypertension (HTN), type 2 diabetes (DM2) or impaired glucose tolerance (IGT); and (2) screening and initial management of obesity among unselected patients of PCPs who practice in FMGs.
The effect of sitagliptin on postprandial lipoprotein metabolism in patients with diabetes mellitus type 2
Sep 2009The main objective of the study is to evaluate whether treatment with sitagliptin (100 mg/d) for 10 weeks will result in an improvement of postprandial lipoprotein metabolism compared to glimepiride (1 mg/d) despite similar HbA1c reduction in drug naive type 2 diabetic patients.
A Double-Blind, Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Sep 2009The primary objective of this phase III study in subjects with differentiated thyroid cancer (papillary, follicular, Hurthle cell carcinoma) who are refractory to radioactive iodine treatment is to compare the treatment groups in terms of progression free survival (PFS) evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
A Phase III, randomised, double-blind, placebo-controlled parallel group efficacy and safety study of linagliptin 5 mg administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with pioglitazone
Sep 2009The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Phase II randomized trial of MEK inhibitor AS703026 or placebo combined with gemcitabine in chemo-naïve metastatic pancreas cancer subjects
Sep 2009To evaluate the anti-tumor activity of AS703026 combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma.
Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244
Sep 2009The purpose of this study is to find out if the drug AZD6244 can improve the radioactive iodine uptake by the patient's metastatic thyroid cancer.
A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin
Aug 2009The primary objective of this study is to assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to insulin glargine and metformin in terms of HbA1c change over a period of 24 weeks.
Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c >= 6 % or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure.
Jul 2009To evaluate safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c ≥ 6% or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure (Proof of Concept).
Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology.
Jun 2009In patients with medullary thyroid cancer [MTC] or radioiodine (131*I) refractory/resistant differentiated thyroid cancer[DTC]: to determine the effect of E7080 on the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) by independent imaging review (IIR).
A phase III randomised, double-blind parallel group extension study to investigate the safety and efficacy of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46
May 2009The objective of the current study is to investigate the safety and efficacy of linagliptin 2.5 mg plus metformin either 500 mg or 1000 mg, twice daily in comparison to metformin 1000 mg monotherapy twice daily given for 54 weeks.
Studying Biomarkers in Patients With Pancreatic Cancer
May 2009This research study is looking at biomarkers in patients with pancreatic cancer.
Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer
May 2009This laboratory study is looking at biomarkers in predicting response to treatment in patients who have undergone surgery for pancreatic cancer.
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination with Metformin in Subjects with Type 2 Diabetes
May 2009To evaluate the durability (for up to approximately 2 years) of the efficacy of alogliptin plus metformin as compared to glipizide plus metformin as measured by HbA1c change from baseline to Week 52 or 104 in adults with type 2 diabetes mellitus.
A Phase II study in patients with locally advanced pancreatic carcinoma: ARC-II – Akt-inhibition by Nelfinavir plus chemoradiation with gemcitabine and cisplatin
Apr 2009To assess if the addition of nelfinavir to gemcitabine and cisplatin chemoradiotherapy improves survival and merits further study.
Phase II Trial of the effect of Gemcitabine with intravenous omega 3 fish oil infusion in patients with unresectable pancreatic adenocarcinoma
Apr 2009Objective response rate (complete + partial response) of response of patients receiving gemcitabine plus parenteral omega-3.
Sleep and Obesity in Teenagers
Feb 2009This study aims to investigate 1.whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers, 2.the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers
Gemcitabine combined with the mTOR inhibitor Temsirolimus (CCI-779) in patients with inoperable or metastatic pancreatic cancer
Feb 2009The primary objective of this study is to determine the maximum tolerated dose and recommended phase II dose of temsirolimus and gemcitabine in patients with pancreatic cancer, and to estimate the progression free survival in patients treated with the temsirolimus+gemcitabine combination.
A Phase 1 Trial of Verteporfin Photodynamic Therapy in Unresectable Pancreatic Carcinoma (VERTPAC-01 study)
Jan 2009The trial aims to investigate the safety and efficacy of verteporfin photodynamic therapy in patients with locally advanced pancreatic carcinoma. The primary endpoint is the diameter of necrosis of tumour achieved around a single fibre for a given light energy.
An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer
Nov 2008To evaluate progression free survival (PFS) with XL184 treatment as compared with placebo in subjects with unresectable, locally advanced or metastatic medullary thyroid carcinoma (MTC).
A phase II trial to assess the efficacy of efavirenz as second-line monotherapy for the treatment of advanced pancreatic adenocarcinomas.
Oct 2008Evaluation of the efficacy of efavirenz as second-line monotherapy for the treatment of advanced pancreatic adeno-carcinomas in terms of non-morphological progression at 2 months.
New therapeutic approaches for anaplastic thyroid cancer: assessment of the benefit-risk profile of the combination valproic acid-paclitaxel.
Sep 2008Evaluation of the antitumour efficacy of valproic acid and paclitaxel in patients with undifferentiated thyroid cancer
Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer
Sep 2008This study will evaluate the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer.
A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 on top of pioglitazone in patients with type 2 diabetes not adequately controlled with pioglitazone.
Aug 2008The primary objective of this study is to assess the efficacy of AVE0010 on glycemic control in comparison to placebo as an add-on treatment to pioglitazone in Type 2 Diabetes patients treated with pioglitazone in terms of absolute HbA1c reduction over a period of 24 weeks.
Computer Tools for Improving Early Diagnosis and Treatment in Healthy Volunteers or Patients With Pancreatic Cancer or Who Are At Risk For Pancreatic Cancer or Who Have a Noncancer Pancreatic Disorder
Aug 2008This clinical trial is studying computer tools for improving early diagnosis and treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a non-cancerous pancreatic disorder.
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery
Aug 2008This randomized clinical trial is studying the side effects of vaccine therapy and to see how well it works when given with or without cyclophosphamide in treating patients undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that can be removed by surgery.
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM)
Jun 2008The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).
A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen
May 2008To determine whether single agent larotaxel increases overall survival when compared to continuous administration of 5-Fluorouracil (5-FU) in patients with advanced pancreatic cancer previously treated with a gemcitabine-based therapy
Sutent Adjunctive Treatment of Differentiated Thyroid Cancer (IIT Sutent)
Apr 2008This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates.
Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
Mar 2008Effect of n-3 polyunsaturated fatty acids (n-3 PUFA; Omacor®) on visceral adipose tissue inflammation
Pazopanib in Treating Patients With Advanced Thyroid Cancer
Feb 2008This phase II trial is studying the side effects and how well pazopanib works in treating patients with advanced thyroid cancer.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of Pf-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment
Feb 2008To evaluate the effect of two oral doses of PF-00734200 on change from baseline to 12 weeks in HbA1c levels in subjects with T2DM on metformin.
A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
Feb 2008To assess the HbA1c-lowering efficacy of sitagliptin compared to metformin after 24 weeks of treatment. To assess the safety and tolerability of sitagliptin over 24 weeks of treatment.
Phase 2 trial with Avastin and Doxorubicin postoperatively for patients with anaplastic thyroid carcinoma
Jan 2008To assess overall survival and response rate (recist)
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial
Jan 2008To determine whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), Statins, or a combination of both, when compared with placebo, will reduce urinary albumin excretion, decline in renal function and the risk for diabetic nephropathy (DN) and cardiovascular disease (CVD)
Mitochondrial Function in Pediatric Obesity
Dec 2007This study evaluates a novel, non invasive, safe method for predicting insulin resistance and diabetes in children using a magnetic resonance imaging (MRI) based technique to measure mitochondrial function. We propose to investigate mitochondrial function and glucose metabolism in obese and non-obese children in early, mid and late puberty.
New therapeutic approaches in the treatment of anaplastic thyroid cancer: a phase II trial of valproic acid and paclitaxel in solid tumours
Dec 2007Evaluation of the antitumour activity of valproic acid and paclitaxel in patients with anaplastic thyroid cancer
Vaccine Study for Surgically Resected Pancreatic Cancer
Dec 2007To assess the response for subjects with pancreatic cancer that have undergone surgical resection and treatment with a vaccine given with chemotherapy and chemoradiation.
A Multicenter, Open-Label, Randomized Study Comparing the Efficacy and Safety of S-1 as a Single Agent at 30 mg/m2 BID versus 5-FU Bolus Infusion for the Treatment of Patients with Metastatic Pancreatic Cancer Previously Treated with a Gemcitabine Based-Regimen
Oct 2007To determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 versus Placebo in Subjects with Diabetic Neuropathic Pain
Oct 2007To compare the analgesic efficacy and the safety of ABT-894 (6 mg tablets) administered twice daily (BID) to placebo in the treatment of diabetic neuropathic pain (DNP).
A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality.
Sep 2007The primary objective of this study is to determine whether aliskiren, when added to conventional treatment, compared to placebo, delays the occurrence of cardiovascular and /or renal complications in patients with type 2 diabetes at high risk for cardiovascular and renal events.
Pancreatic Cancer Genetic Epidemiology (PACGENE) Study
Sep 2007Our study is part of a multicenter, multidisciplinary Pancreatic Cancer Genetic Epidemiology (PACGENE) consortium to identify susceptibility genes in high risk FPC pedigrees using cutting-edge genetic analysis methods.
A Pilot study to evaluate the Efficacy and Safety of GFT505 orally administered once daily (30 mg) for 28 days in atherogenic dyslipidaemic patients with abdominal obesity. A double blind, placebo-controlled and randomized study.
Aug 2007To evaluate the efficacy of GFT505 30 mg in reducing serum TG and increasing HDL-C levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity. To assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.
A multicenter, open-label, randomized, phase II/III study to evaluate the safety and efficacy of combretastatin a-4 phosphate in combination with paclitaxel and carboplatin in comparison with paclitaxel and carboplatin against anaplastic thyroid carcinoma
Jul 2007To compare the antineoplastic efficacy of combretastatin A-4 phosphate + paclitaxel + carboplatin+ with paclitaxel + carboplatin against anaplastic thyroid carcinoma by measuring overall survival
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Jul 2007The aim of this study is to determine if early and tight restoration of metabolic control at the onset of Type 1 diabetes (T1DM) will improve insulin secretion (C-peptide production) versus routine diabetes management.
A phase II study to evaluate the efficacy of bevacizumab in combination with capecitabine and concomitant radiotherapy in patients affected by non-resectable locally advanced pancreatic cancer.
Jul 2007To evaluate the overall survival after 1 year of treatment with bevacizumab in combination with capecitabine and concomitant radiotherapy in patients affected by non-resectable locally advanced pancreatic cancer.
Observational Study of Early Metabolic and Vascular Changes in Obesity (STYJOBS/EDECTA)
Jun 2007a prospective, observational study to improve the understanding of atherosclerosis, cardiovascular risk, low grade inflammation, and metabolic changes in obesity by investigation of the "non-biased" early phase
The effect of Pioglitazone on vascular and ventricular function in people with type 2 diabetes PICCOLA
May 2007This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the effects of insulin-sensitizing agent pioglitazone, on heart and artery function.
Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction with Radioiodine for the Treatment of Multinodular Goiter
Apr 2007The objective of this study is to determine the dose-response and safety of 2 doses of MRrhTSH with radioiodine (131I) therapy to achieve goiter shrinkage and improve goiter symptoms compared with 131I therapy alone in an adult population with small to moderate-sized multinodular goiter.
The Effect of a Diabetes Action Team in Patients Post Infrainguinal Bypass Surgery With and Without Diabetes
Apr 2007Diabetes is a very common illness. Approximately 4% of British Columbians have diabetes. However, at least 20% of people admitted to acute care hospitals have diabetes. People with diabetes are at a higher risk for developing complications after surgery including infection and prolonged hospital stay, especially if blood sugars are high. The researchers are testing a Diabetes Action Team to see if their involvement in patient care after surgery improves blood glucose control, duration of stay in hospital, and infection rates.
An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMA ) versus Placebo in Subjects with Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer.
Mar 2007To demonstrate an improvement in progression-free survival (PFS) with ZD6474 as compared to placebo in subjects with unresectable locally advanced or metastatic MTC
Evaluation clinique de la 18 F-F Dopa en tomographie par émission de positons dans les cancers médullaires de la thyroïde.
Jan 2007Evaluer l'apport de la 18F-FDOPA dans la détection du tissu tumoral chez des patients suivis pour un cancer médullaire de la thyroïde présentant une maladie résiduelle diagnostiquée par un taux élevé du marqueur tumoral, la calcitonine, associé ou non à un taux élevé d'Anticorps Carcino-Embriologique et chez lesquels les examens morphologiques ou fonctionnels n'ont pas pu identifier avec certitude le site tumoral.
A 2-year, randomized, double-blind, placebo-controlled phase 3 study to evaluate the long-term efficacy and safety of CP-945,598 in the treatment of obese subjects
Jan 2007Determine the long term efficacy of CP 945,598 on body weight in obese subjects or overweight subjects with co morbid conditions after 1 and 2 years of dosing.
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Jan 2007The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
A randomized, double blind, two arm, parallel, placebo controlled study of rimonabant 20mg effect on high density lipoprotein kinetics in patients with abdominal obesity and additional cardiometabolic risk factors
Dec 2006The Primary End-point is the fractional catabolic rate of ApoA-I in HDL after 12 months of treatment.
Phase II Trial of Docetaxel in Patients With Metastatic or Inoperable Medullary Thyroid Cancer
Dec 2006To evaluate the capacity of Docetaxel (TAXOTERE®) to induce objective responses in patients with metastatic or locally inoperable medullary thyroid cancer or at relapse after surgery or immunotherapy.
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
Dec 2006The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.
The Effect of Treating Patients with Anaemia in Diabetic Nephropathy to different target haemoglobin levels with Epoetin Beta
Nov 2006To determine whether treating patients with Anaemia and Diabetic Nephropathy with EPOETIN BETA to different target haemoglobin ranges has an effect on rate of deterioration of renal function, need for dialysis and death.
A 52-week multicenter, open-label, randomized, parallel, two - arm study comparing Exubera® (inhaled human insulin) vs. Humalog® (insulin lispro), both in combination with insulin glargine in subjects with type 1 diabetes mellitus - protocol A2171035.
Nov 2006The primary objective of the study is to demonstrate non-inferiority of an insulin regimen using insulin glargine as the basal insulin with Exubera as the mealtime insulin, compared to a regimen using insulin glargine as the basal insulin and insulin lispro as the mealtime insulin in terms of glycemic control (HbA1c) after 52 weeks of treatment with each treatment regimen.
Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Oct 2006This phase II trial is studying the side effects and how well vaccine therapy works in treating patients with pancreatic cancer that has been removed by surgery.
A Phase IIb/III Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Obese Patients and in Overweight Patients with Obesity-related Co-morbidities.
Sep 2006In obese patients and in overweight patients with obesity-related co-morbidities, to assess the effects of MK-0364 after 1 year of treatment on: 1. body weight; 2. safety and tolerability during treatment.
A Phase II, Open-Label Study To Assess The Efficacy and Tolerability of ZD6474 (ZACTIMA™ ) 100 mg Monotherapy In Subjects with Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
Apr 2006To determine the objective response rate in subjects treated with ZD6474 (ZACTIMA™ ) 100 mg monotherapy
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