Study S000604

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)

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02963766
Acronym: AWARD-PEDS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 154
Start: 2016-12-29
Primary completion: 2021-06-12
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Dulaglutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:H9X-MC-GBGC; EUDRACT_NUMBER:2016-000361-22; NIH:2016

Registered primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 [Baseline, Week 26]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT02963766; registry reference DERIVED:39963952
R0010336	Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. Arslanian SA, The New England journal of medicine	2022	Randomized trial	PMID 35658022 DOI	cites ClinicalTrials.gov:NCT02963766; registry reference DERIVED:35658022