Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 353
Healthy volunteers: no

Brief summary:
The purpose of this 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 100 mg arm 2: Placebo

Interventions: intervention 1: Comparator: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Comparator: Pioglitazone intervention 4: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24 intervention 2: Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24 intervention 3: Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8 intervention 4: Metformin rescue for patients meeting

pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

Protocol document: