GSK announces progress in HARMONY Syncria programme for Type 2 Diabetes

Topline results have been received from seven of the eight �HARMONY� Phase III studies investigating the use of Syncria (albiglutide) from GSK in Type 2 Diabetes. Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist. In HARMONY 6, the second of the phase III �HARMONY� studies to complete, albiglutide was compared to preprandial insulin, each administered on top of long-acting insulin glargine. In this study, the first of its kind for the class, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus preprandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint. Results showed a reduction in HbA1c from baseline of 0.82% for patients receiving albiglutide compared to a reduction of 0.66% for preprandial lispro insulin (p<0.0001 for non-inferiority). weight change from baseline was -0.73kg in the albiglutide arm and +0.81kg in the preprandial lispro insulin arm (p><0.0001 for treatment difference). the most common adverse events observed more frequently in the albiglutide arm than the comparator arm, in this 52 week study, were gastrointestinal in nature; nausea (13% for albiglutide versus 2.1% for preprandial lispro insulin) and vomiting (7% for albiglutide versus 1.4% for preprandial lispro insulin).gsk anticipates data from both harmony 6 and harmony 7 will be presented at a scientific meeting in 2012. results from the other six studies will be submitted for presentation and publication, once the studies complete.>