drugset / Trial / NCT02963766
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2016-12-29
- Primary completion
- 2021-06-12
- Completion
- 2022-01-12
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Pooled Dulaglutide; p <0.001; LS Mean difference (Final Values) -1.3 (95% CI -1.8 to -0.7); Mixed Models Analysis NCT02963766 ↗
release “Youth and adolescents achieved superior A1C reductions on both doses of Trulicity in AWARD-PEDS compared to participants randomized to the placebo group.” lilly.com ↗
release “The study achieved this primary objective” lilly.com ↗
Publications
- Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
- Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Perez M, Bismuth E, Dib S, Cho JI, Cox D; AWARD-PEDS Investigators. Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. N Engl J Med. 2022 Aug 4;387(5):433-443. doi: 10.1056/NEJMoa2204601. Epub 2022 Jun 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dulaglutide | Peptide | 0.75 mg | Subcutaneous |
| Subject | Dulaglutide | Peptide | 1.5 mg | Subcutaneous |