213
Participants
Start Date
October 2, 2012
Primary Completion Date
January 19, 2016
Study Completion Date
January 19, 2016
Omarigliptin
Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week
Placebo to omarigliptin
Matching placebo to omarigliptin capsule administered orally once a week
Glipizide
Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Placebo to glipizide
Matching placebo to glipizide daily
Insulin
Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.
Merck Sharp & Dohme LLC
INDUSTRY