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A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

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Trial Profile

A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2022

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At a glance

  • Drugs Sitagliptin (Primary) ; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Merck Sharp & Dohme

    • Most Recent Events

    • 29 Jun 2021 Results presented at the 81st Annual Scientific Sessions of the American Diabetes Association
    • 29 Jun 2021 Results of a pooled analysis comparing the characteristics of younger (Y, 10-14 yrs) vs. older (O, 15-17 yrs) patients in global clinical trials of sitagliptin as initial oral therapy (IOT, NCT01485614) or as add-on to metformin therapy (AMT, NCT01472367, NCT01760447). presented at the 81st Annual Scientific Sessions of the American Diabetes Association
    • 23 Nov 2020 Planned number of patients changed from 220 to 360.

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