506
Participants
Start Date
December 16, 2015
Primary Completion Date
December 27, 2017
Study Completion Date
December 27, 2017
Ertugliflozin 5 mg
Ertugliflozin 5 mg oral tablet taken once daily
Ertugliflozin 15 mg
Ertugliflozin 15 mg (5-mg and 10-mg tablets) oral taken once daily
Placebo matching ertugliflozin
Placebo matching ertugliflozin (5-mg and/or 10-mg tablet) oral taken once daily
Metformin
Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily.
Glimepiride
Glycemic rescue therapy with open-label glimepiride will be initiated in participants with glucose values exceeding protocol-specified values. Dosing and titration of open-label glimepiride rescue therapy will be at the Investigator's discretion.
Collaborators (1)
Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY