402
Participants
Start Date
January 11, 2013
Primary Completion Date
March 16, 2016
Study Completion Date
March 16, 2016
Omarigliptin
Omarigliptin 25 mg capsule administered orally once weekly (preferably on the same day of each week)
Matching placebo to omarigliptin
Matching placebo to omarigliptin capsule administered orally once weekly (preferably on the same day of each week)
Glimepiride
Glimepiride 1 or 2 mg tablet/capsule administered orally once daily and up-titrated to a maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.
Matching placebo to glimepiride
Matching placebo to glimepiride tablet/capsule administered orally once daily and up-titrated to a mock maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.
Insulin glargine
During Phase B of the study, participants who received a maximum up-titration of open-label glimepiride or blinded glimepiride/matching placebo to glimepiride, may be rescued with open-label insulin glargine.
Metformin
Participants continue stable pre-study dose of metformin tablet(s) administered orally (\>= 1500 mg daily) throughout the study.
Merck Sharp & Dohme LLC
INDUSTRY