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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Diet and Exercise

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Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Diet and Exercise

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Ertugliflozin (Primary) ; Sitagliptin (Primary) ; Glimepiride
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VERTIS; VERTIS SITA
  • 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.
  • 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
  • 20 Mar 2018 risk of UTIs, including complicated UTIs, in adult patients with T2DM receiving ertugliflozin relative to placebo or active comparators from 7 trials (NCT [VERTIS name]: 01958671 [MONO], 02036515 [SITA2], 02033889 [MET], 01986855 [RENAL], 01999218 [SU], 02099110 [FACTORIAL], 02226003 [SITA]) presented at The 100th Annual Meeting of the Endocrine Society

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