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

H9X-MC-GBGC -

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.

Trial Summary

Age Range
10 - 17 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
Dulaglutide
Could I receive a Placebo?
Yes
Enrollment Goal
154
Trial Dates
Dec 29, 2016 - Jan 12, 2022
How long will I be in the trial?
Your participation could last up to 60 weeks and include 8 visits to the study center.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Pediatric participant (child or teen) must have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin

  • Pediatric participant must be on a stable dose of metformin and/or basal insulin for at least 8 weeks

Participants Must Not:

  • Pediatric participant must not have type 1 diabetes

  • Female participant who are having menstrual period must be on birth control if sexually active

  • Pediatric participant must not be taking any medicine for diabetes other than metformin and/or basal insulin and must have stopped any other diabetic medicine at least 3 months prior to starting the first study visit

  • Pediatric participant must not have taken oral steroids within the last 60 days

  • Pediatric participant must not have used prescription weight loss medications in the last 30 days, or plan to use

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