A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

Phase 4 Completed 12 enrolled Eli Lilly and Company

RandomizedCrossoverSingle-blindTreatment

Summary

The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.

Timeline

Start: 2017-10-28
Primary completion: 2018-02-28
Completion: 2018-02-28

Outcome

Met primary endpoint

registry analysis (superiority test); Dulaglutide vs Placebo; p < 0.0001; Mean Difference (Final Values) -254.02 (95% CI -337.76 to -170.28) NCT03315780 ↗

paper The decrease in AUC (0-4 h) from baseline to week 4 following dulaglutide administration was statistically significant compared with placebo PMID 30949907 ↗

Publications

Inoue M, Shiramoto M, Oura T, Nasu R, Nakano M, Takeuchi M. Effect of Once-Weekly Dulaglutide on Glucose Levels in Japanese Patients with Type 2 Diabetes: Findings from a Phase 4, Randomized Controlled Trial. Diabetes Ther. 2019 Jun;10(3):1019-1027. doi: 10.1007/s13300-019-0605-7. Epub 2019 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dulaglutide	Peptide	0.75 mg	Subcutaneous