Study S001400

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04809220
Acronym: AWARD-JPN
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 591
Start: 2021-04-13
Primary completion: 2022-10-01
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Hypoglycemic Agents; Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG:Dulaglutide; DRUG:Oral antihyperglycemics
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:H9X-JE-GBGQ

Registered primary outcomes

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

Linked records (1)

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
R0017539	A randomized, double-blind trial assessing the efficacy and safety of two doses of dulaglutide in Japanese participants with type 2 diabetes (AWARD-JPN). Morioka T, Diabetes, obesity & metabolism	2024	Randomized trial	PMID 38715179 DOI	cites ClinicalTrials.gov:NCT04809220