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A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

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Trial Profile

A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Omarigliptin (Primary) ; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.
  • Most Recent Events

    • 27 Aug 2019 Results assessing population pharmacokinetic and pharmacodynamic model by using data from phase I, II and III studies including this study published in the British Journal of Clinical Pharmacology.
    • 28 Sep 2015 According to a Merck media release, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved MARIZEV (omarigliptin) 25 mg and 12.5 mg tablets for the treatment of adults with type 2 diabetes. Merck plans to submit omarigliptin for regulatory approval in the United States by the end of 2015.
    • 19 Sep 2014 Results presented at the 50th Annual Meeting of the European Association for the Study of Diabetes.
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