Efficacy and Safety of TAK-875 in Subjects With Type 2 Diabetes Mellitus

Phase 2 Completed 426 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the safety and efficacy of multiple doses of TAK-875, once daily (QD), in subjects with Type 2 Diabetes Mellitus.

Timeline

Start: 2009-12
Primary completion: 2010-09
Completion: 2010-09

Outcome

Met primary endpoint

paper At week 12, significant least-squares mean reductions in HbA(1c) from baseline occurred in all TAK-875 PMID 22374408 ↗

Publications

Results Burant CF, Viswanathan P, Marcinak J, Cao C, Vakilynejad M, Xie B, Leifke E. TAK-875 versus placebo or glimepiride in type 2 diabetes mellitus: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2012 Apr 14;379(9824):1403-11. doi: 10.1016/S0140-6736(11)61879-5. Epub 2012 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fasiglifam	Small molecule	6.25 mg	Oral
Subject	Fasiglifam	Small molecule	25 mg	Oral
Subject	Fasiglifam	Small molecule	50 mg	Oral
Subject	Fasiglifam	Small molecule	100 mg	Oral
Subject	Fasiglifam	Small molecule	200 mg	Oral
Comparator	Glimepiride	Small molecule	2 mg	Oral
Comparator	Glimepiride	Small molecule	4 mg	Oral