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