Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

Brief summary:
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Detailed description:

Arms:
arm 1: sitagliptin + metformin arm 2: metformin + any other oral antidiabetic drug arm 3: metformin

Interventions: intervention 1: sitagliptin phosphate intervention 2: Comparator: metformin intervention 3: Comparator: metformin intervention 4: Comparator: Antidiabetic Standard of Care
Intervention descriptions: intervention 1: sitagliptin 100 mg Once a day (QD) for 24 weeks intervention 2: metformin 850 mg Twice a day (BID) for 24 weeks intervention 3: metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks intervention 4: Patient can take any oral antidiabetic drug (other than metformin)

Protocol document: