8,246
Participants
Start Date
November 4, 2013
Primary Completion Date
December 27, 2019
Study Completion Date
December 27, 2019
Ertugliflozin
Oral, once daily, for up to approximately 6 years
Placebo
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Glycemic Rescue
Doses of background anti-hyperglycemic agents (AHA), medications will be required to be held constant in all participants enrolled for the initial 18 weeks of the trial with 2 exceptions: First, participant will be prescribed glycemic rescue therapy if they meet specific, progressively more stringent, glycemic thresholds based on repeated, confirmed fasting plasma glucose (FPG) measured at a central laboratory. Second, a participant experiencing clinically significant hypoglycemia according to the investigator at any time during the trial is permitted to have the dose of appropriate background AHA (e.g., insulin, sulfonylurea \[SU\], glinide) reduced or discontinued as per the judgment of the investigator or the treating physician. Choice and dosing of glycemic rescue will be at the discretion of the investigator or the treating physician consistent with standards of care for management of patients with Type 2 diabetes mellitus (T2DM) within the country of the investigational site.
Collaborators (1)
Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY