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A Phase III Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-dose Combination Tablet of Sitagliptin and Extended-release Metformin) in Pediatric Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin)

Trial Profile

A Phase III Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-dose Combination Tablet of Sitagliptin and Extended-release Metformin) in Pediatric Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2019

At a glance

  • Drugs Metformin/sitagliptin (Primary) ; Insulin glargine; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • Most Recent Events

    • 06 Dec 2018 Planned End Date changed from 23 Sep 2019 to 13 Sep 2019.
    • 06 Dec 2018 Planned primary completion date changed from 23 Sep 2019 to 13 Sep 2019.
    • 03 Oct 2018 This trial has been completed in Greece, according to European Clinical Trials Database record
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