A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
Phase of Trial: Phase III
Latest Information Update: 13 Jun 2017
At a glance
- Drugs Ertugliflozin (Primary) ; Glimepiride; Metformin
- Indications Type 2 diabetes mellitus
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms VERTIS
- Sponsors Merck Sharp & Dohme
- 10 Jun 2017 Biomarkers information updated
- 26 Apr 2017 Status changed from active, no longer recruiting to completed.
- 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.