Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 660
Healthy volunteers: no

Brief summary:
The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with metformin. The primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of insulin relative to placebo.

Detailed description:

Arms:
arm 1: Sitagliptin 100 mg once daily arm 2: Placebo to sitagliptin once daily

Interventions: intervention 1: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Insulin Glargine intervention 4: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet once daily for 24 weeks intervention 2: Placebo to sitagliptin once daily for 24 weeks intervention 3: Participants on insulin glargine or another insulin regimen for at least 10 weeks prior to screening will continue or switch to open-label insulin glargine once-daily in the evening for the duration of the study. intervention 4: Participants on metformin oral tablet(s) at a dose of at least 1500 mg/day for at least 10 weeks prior to screening will continue receiving metformin at their current dose for the duration of the study.

Protocol document: