Conditions: Type 2 Diabetes Mellitus (T2DM)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 190
Healthy volunteers: no

Brief summary:
A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day intervention 2: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Intervention descriptions: intervention 1: Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets. intervention 2: Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

Protocol document: