A Study for Patients With Type 2 Diabetes Mellitus

Phase 2 Completed 247 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.

Timeline

Start: 2008-12
Primary completion: 2010-01
Completion: 2010-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); 0.5 mg LY2428757 vs Placebo; p = 0.0109; Difference in mean change from baseline -0.47 (95% CI -0.83 to -0.11) NCT00804986 ↗

registry analysis (superiority or other test); 12.0 mg LY2428757 vs Placebo; p <0.0001; Difference in mean change from baseline -1.28 (95% CI -1.64 to -0.93) NCT00804986 ↗

Publications

Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY2428757	Unknown	0.5 mg	Subcutaneous
Subject	LY2428757	Unknown	2 mg	Subcutaneous
Subject	LY2428757	Unknown	6.2 mg	Subcutaneous
Subject	LY2428757	Unknown	12 mg	Subcutaneous
Subject	LY2428757	Unknown	17.6 mg	Subcutaneous