Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 521
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Detailed description:

Arms:
arm 1: Sitagliptin 100 mg arm 2: Sitagliptin 200 mg arm 3: Placebo/Pioglitazone

Interventions: intervention 1: Comparator: sitagliptin 100 mg intervention 2: Comparator: sitagliptin 200 mg intervention 3: Comparator: placebo intervention 4: Comparator: pioglitazone
Intervention descriptions: intervention 1: sitagliptin 100 mg oral tablet once daily for 54 weeks intervention 2: sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks intervention 3: placebo oral tablet once daily during Phase A (Weeks 0-18) intervention 4: pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

Protocol document: