329
Participants
Start Date
December 5, 2012
Primary Completion Date
June 19, 2015
Study Completion Date
June 19, 2015
Omarigliptin
Omarigliptin 25 mg capsule administered orally once a week.
Placebo to Omarigliptin
Placebo to omarigliptin capsule administered orally once a week
Metformin
If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin during Phase A will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily) in Phase B. Participants in the omarigliptin treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study.
Placebo to metformin
During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).
Glimepiride
If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy
Merck Sharp & Dohme LLC
INDUSTRY