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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin

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Trial Profile

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2022

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At a glance

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

Most Recent Events

  • 11 Apr 2019 This trial has been completed in Spain, according to European Clinical Trials Database.
  • 15 Sep 2017 Results (n=1299) of pooled analysis of 2 trials (NCT00395343 and NCT01462266) presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes
  • 09 Jun 2015 Results of subgroup analysis (assessing incidences of hypoglycaemia) presented at the 75th Annual Scientific Sessions of the American Diabetes Association.

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