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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

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Trial Profile

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Ertugliflozin (Primary) ; Glimepiride; Insulin glargine; Metformin; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VERTIS; VERTIS SITA2
  • Sponsors Merck & Co; Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

    • Most Recent Events

    • 26 Mar 2020 Results (n=1544) of post hoc and pooled analysis from NCT01958671, NCT02033889, and NCT02036515 assessing Efficacy and Safety of Ertugliflozin in Patients with Overweight and Obesity with Type 2 Diabetes Mellitus, published in the Obesity (Silver Spring, Md.)
    • 06 Dec 2019 Results (n=335) of pooled analysis from VERTIS MET, VERTIS SITA2 and VERTIS SU comapring efficacy of ertugliflozin between patients from East Asian and non-East Asian sites, presented at the 2019 Congress of the International Diabetes Federation
    • 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.
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