464
Participants
Start Date
March 12, 2014
Primary Completion Date
June 6, 2016
Study Completion Date
June 6, 2016
Ertugliflozin 5 mg
Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks
Ertugliflozin 15 mg
Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks
Placebo for ertugliflozin 5 mg
Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks
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.
Sitagliptin
Participants are to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.
Glimepiride
Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion
Insulin
Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine can be initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.
Placebo for ertugliflozin 10 mg
Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks
Collaborators (1)
Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY