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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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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; 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.)
    • 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.
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