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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin and Metformin Fixed Dose Combination, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes Mellitus

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin and Metformin Fixed Dose Combination, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 May 2017

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At a glance

  • Drugs Alogliptin/metformin (Primary) ; Alogliptin; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 28 Sep 2016 Results published in the Takeda Media Release
    • 28 Sep 2016 According to a company media release, Takeda has obtained the New Drug Application Approval from the Ministry of Health, Labour and Welfare for the Inisync Combination Tablets, a fixed-dose combination of Nesina and metformin hydrochloride for the treatment of type 2 diabetes, based on the results of this and other trials (see profile 250740).
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