200
Participants
Start Date
February 10, 2012
Primary Completion Date
October 9, 2019
Study Completion Date
October 9, 2019
Sitagliptin
Sitagliptin 100 mg tablet administered orally once daily
Metformin
Metformin 500 mg tablets administered orally starting at 500 mg/day and uptitrated by 500 mg every week to a final dose of 1000 mg twice daily
Placebo to sitagliptin
Matching placebo to sitagliptin 100 mg tablet administered orally once daily
Placebo to metformin
Matching placebo to metformin 500 mg tablets, 2 tablets administered orally twice daily
Glycemic Rescue 1
Participants in the sitagliptin arm who require glycemic rescue will receive metformin during Weeks 0-20 and Weeks 20-54. Participants in the placebo arm who require glycemic rescue will receive metformin during Weeks 0-20. Participants in the placebo arm who have switched to metformin during Weeks 20-54 and require glycemic rescue will receive sitagliptin.
Glycemic Rescue 2
Participants who require glycemic rescue after Glycemic Rescue 1 will receive open-label insulin. Participants on background insulin therapy will have the dose of their background insulin up-titrated.
Merck Sharp & Dohme LLC
INDUSTRY