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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2017

At a glance

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

    • 10 Jun 2017 Biomarkers information updated
    • 28 Oct 2015 No of arms changed from 2 to 10 as reported by ClinicalTrials.gov record.
    • 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.
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