A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus

Phase 3 Completed 361 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).

Timeline

Start: 2012-04
Primary completion: 2013-07
Completion: 2013-07

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); LY2189265 + OAM vs Insulin Glargine + OAM; p <0.001; LS Mean Difference -0.54 (95% CI -0.67 to -0.41) NCT01584232 ↗

Publications

Suzuki S, Oura T, Takeuchi M, Boye KS. Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies. Health Qual Life Outcomes. 2017 Jun 12;15(1):123. doi: 10.1186/s12955-017-0696-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dulaglutide	Peptide	0.75 mg	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous
Background	Gliclazide	Small molecule	—	—
Background	Glimepiride	Small molecule	—	—
Background	Glyburide	Small molecule	—	—
Background	Metformin	Small molecule	—	—
Background	buformin	Small molecule	—	—