A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

Phase 4 Completed 159 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.

Timeline

Start: 2016-08
Primary completion: 2018-06-18
Completion: 2018-06-18

Outcome

Met primary endpoint

paper The LS mean and 95% confidence interval for the difference were - 1.50% (- 1.73%, - 1.28%) and dulaglutide was superior to placebo. PMID 31758520 ↗

registry analysis (superiority test); Placebo; p <0.001; LS mean percent difference -1.50 (95% CI -1.73 to -1.28); Mixed Models Analysis NCT02750410 ↗

Publications

Onishi Y, Ishii H, Oura T, Takeuchi M. Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen. Diabetes Ther. 2020 Mar;11(3):735-745. doi: 10.1007/s13300-020-00765-6. Epub 2020 Jan 29.
Ishii H, Onishi Y, Oura T, Takeuchi M. Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study. Diabetes Ther. 2020 Jan;11(1):133-145. doi: 10.1007/s13300-019-00726-8. Epub 2019 Nov 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dulaglutide	Peptide	0.75 mg	Subcutaneous