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A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2022

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At a glance

  • Drugs Fasiglifam (Primary) ; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda
  • Most Recent Events

    • 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 Nov 2012 New source identified and integrated (European Clinical Trials Database: EudraCT2011-001752-10).

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