Study S000046

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus

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

Registration

Registration: NCT03495102
Acronym: AWARD-11
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 1842
Start: 2018-04-05
Primary completion: 2019-05-28
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Dulaglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:H9X-MC-GBGL; EUDRACT_NUMBER:2017-003490-33; NIH:2017

Registered primary outcomes

Change in Hemoglobin A1c (HbA1c) From Baseline [Baseline, Week 36]

Linked records (3)

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
R0008191	Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Ferdinand KC, Cardiovascular diabetology	2023	Systematic review	PMID 36894938 DOI	cites ClinicalTrials.gov:NCT03495102; registry reference DERIVED:36894938
R0021508	Effect of expanded dulaglutide weekly doses (3.0 mg and 4.5 mg) on cardiovascular disease risk factors in participants with type 2 diabetes at increased cardiovascular disease risk: a post hoc analysis of the AWARD-11 study. Cox DA, Diabetes, obesity & metabolism	2022	Other trial	PMID 35546790 DOI	cites ClinicalTrials.gov:NCT03495102; registry reference DERIVED:35546790
R0022783	Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11). Frias JP, Diabetes care	2021	Randomized trial	PMID 33397768 DOI	cites ClinicalTrials.gov:NCT03495102; registry reference DERIVED:33397768