Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 441
Healthy volunteers: no

Brief summary:
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.

Detailed description:

Arms:
arm 1: Sitagliptin 10 mg tablet daily for 54 weeks arm 2: Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks

Interventions: intervention 1: Comparator: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Comparator: Pioglitazone
Intervention descriptions: intervention 1: sitagliptin 10 mg tablet, once daily for 54 weeks intervention 2: Placebo oral tablet once daily for 24 weeks intervention 3: Pioglitazone 30 mg tablet once daily for 30 weeks

Protocol document: