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A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin Compared With Ertugliflozin Alone and Sitagliptin Alone, in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Metformin Monotherapy

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Trial Profile

A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin Compared With Ertugliflozin Alone and Sitagliptin Alone, in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Metformin Monotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2022

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At a glance

  • Drugs Ertugliflozin (Primary) ; Sitagliptin (Primary) ; Glimepiride; Insulin glargine; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VERTIS Factorial
  • Sponsors Merck & Co; Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

    • Most Recent Events

    • 11 Jun 2019 Results of post hoc analysis of Ertugliflozin efficacy and safety in Hispanic/Latino patients in the Ertugliflozin Phase 3 trials (NCT01958671, NCT02033889, NCT02036515, NCT01999218, NCT02226003, NCT02099110, NCT01986855) presented at the 79th Annual Scientific Sessions of the American Diabetes Association.
    • 17 Oct 2018 Patients were not recruited from United Kingdom.
    • 05 Oct 2018 Results (n=6403) of pooled analysis (VERTIS studies MONO, MET, SITA2, FACTORIAL, SU, SITA, RENAL) assessing the risk of UTIs presented at the 54th Annual Meeting of the European Association for the Study of Diabetes

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