461
Participants
Start Date
October 9, 2013
Primary Completion Date
July 28, 2016
Study Completion Date
July 28, 2016
Ertugliflozin 5 mg
One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
Ertugliflozin 10 mg
One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
Placebo to Ertugliflozin
One placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
Metformin
500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening for 2 weeks and 1000 mg (2 tablets 500 mg) in the morning and 1000 mg (2 tablets 500 mg) in the evening, thereafter.
Placebo to Metformin
1 tablet in the morning and 1 tablet in the evening for 2 weeks, 2 tablets in the morning and 1 tablet in the evening for 2 weeks and 2 tablets in the morning and 2 tablets in the evening, thereafter.
Glimepiride
Dosing and titration of glimepiride as rescue therapy was determined by the investigator.
Collaborators (1)
Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY