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A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2019

At a glance

  • Drugs Ertugliflozin (Primary) ; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VERTIS Mono
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • 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.
    • 11 Jun 2019 Pooled analysis data from VERTIS program (MONO, MET, SITA2) were presented at the 79th Annual Scientific Sessions of the American Diabetes Association.
    • 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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