Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Type 2 Diabetes Mellitus (T2DM)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 211
Healthy volunteers: no

Brief summary:
A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

Detailed description:

Arms:
arm 1: Arm 1: drug arm 2: Arm 2: active comparator arm 3: Arm 3: drug + active comparator arm 4: Arm 4: placebo comparator

Interventions: intervention 1: Comparator: sitagliptin phosphate intervention 2: Comparator: pioglitazone intervention 3: Comparator: placebo to pioglitazone intervention 4: Comparator: placebo to sitagliptin
Intervention descriptions: intervention 1: sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily. intervention 2: pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily. intervention 3: pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily. intervention 4: sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

Protocol document: