A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy

Trial Profile

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2017

At a glance

  • Drugs Ertugliflozin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VERTIS
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 06 Mar 2017 According to a Merck AG media release, the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for ertugliflozin and the two fixed-dose combination tablets (ertugliflozin plus sitagliptin, and ertugliflozin plus metformin). The Prescription Drug User Fee Act (PDUFA) action date from the FDA is in December 2017. These marketing applications to the FDA are supported by studies in the VERTIS clinical development program of ertugliflozin.
    • 06 Mar 2017 According to a Merck AG media release, the European Medicines Agency (EMA) has validated for review three New Drug Applications (NDAs) for ertugliflozin and the two fixed-dose combination tablets (ertugliflozin plus sitagliptin, and ertugliflozin plus metformin).These marketing applications to the EMA are supported by studies in the VERTIS clinical development program of ertugliflozin.
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