A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Phase of Trial: Phase III
Latest Information Update: 28 Feb 2018
At a glance
- Drugs Fasiglifam (Primary) ; Metformin; Sitagliptin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Takeda; Takeda Global Research and Development Center
- 28 Feb 2018 Results of an integrated pooled analysis (n=9139) assessing the hepatic safety of fasiglifam from the data of 15 double-blind studies from both global and Japanese development programs (six phase II and nine phase III) including this study, published in the Drug Safety Journal.
- 27 Dec 2013 Status changed from recruiting to discontinued, as reported by a Takeda media release.
- 10 Aug 2013 New source identified and integrated (European Clinical Trials Database, EudraCT2013-000542-19).