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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 May 2022

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At a glance

  • Drugs Omarigliptin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • 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.
    • 01 Aug 2017 Results published in the Diabetes Therapy.
    • 28 Oct 2015 No of arms changed from 2 to 10 as reported by ClinicalTrials.gov record.
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