GBGC: Comparing efficacy of Dulaglutide vs Placebo in Pediatric DM
Research type
Research Study
Full 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)
IRAS ID
217353
Contact name
Arash Tahbaz
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-000361-22
Duration of Study in the UK
5 years, 1 months, 2 days
Research summary
Summary of Research
Type 2 diabetes mellitus (T2DM) is a disease primarily diagnosed in adults, and the risk of the disease increases with age. However, there has been a significant relative increase in T2DM in teenagers and children in recent years. Unlike adults with T2DM, children and teenagers with T2DM have few approved blood sugar lowering treatment options. Metformin and insulin are the only agents approved in the US and EU for the treatment of children and teenagers with T2DM. Therefore, there is an important need for additional approved agents to treat children and teenagers with T2DM that are safe and effective in this population.
Dulaglutide is a long-acting GLP-1 RA. In 6 Phase 3 studies in adults, once weekly dulaglutide was associated with clinically relevant long-term decreases in glucose concentration. Because of the pathophysiological similarities between T2DM in adults and youth, it is hypothesized that dulaglutide will also have efficacy in the pediatric population with a similar safety profile.
H9X-MC-GBGC is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 clinical trial with an open-label extension to investigate the safety and efficacy of 2 doses of dulaglutide in a pediatric T2DM population.
The study will enrol 150 male and female children and teenagers (ages 10 to <18 years) who have inadequate blood sugar control, despite diet and exercise, with or without metformin and/or basal insulin. The main study has 4 periods: (1) a screening period (2) a double-blind treatment period; (3) an open-label extension period; and (4) a safety follow-up period.
The double-blind portion of the clinical trial will last for 26 weeks and will test placebo against dulaglutide 0.75 and 1.5 mg/week This will be followed by the 26-week open-label period where all patients will receive either dulaglutide 0.75 or 1.5 mg/week, which will be followed by a 30-day safety follow-up.
Summary of Results
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REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0093
Date of REC Opinion
25 Apr 2017
REC opinion
Further Information Favourable Opinion