Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes

Phase 3 Terminated 2454 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM). The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).

Timeline

Start: 2012-01
Primary completion: 2014-03
Completion: 2014-04

Outcome

Outcome not reported

Stopped: “Due to potential concerns about liver safety (See Detailed Description)”

Publications

Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fasiglifam	Small molecule	25 mg	Oral
Subject	Fasiglifam	Small molecule	50 mg	Oral
Comparator	Glimepiride	Small molecule	2 mg	Oral