Clinical trial

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)

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Last updated:29th Dec 2016

Source: clinicaltrials.gov

Identifier: NCT02963766

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)
Actual Study Start Date: December 29, 2016
Estimated Primary Completion Date: June 21, 2021
Estimated Study Completion Date: January 27, 2022

Arms:
- Experimental: Dose 1 Dulaglutide
- Experimental: Dose 2 Dulaglutide
- Placebo Comparator: Placebo

Category	Value
Date last updated at source	2019-07-03
Study type(s)	Interventional
Expected enrolment	150
Study start date	2016-12-29
Estimated primary completion date	2021-06-21

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