Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1246
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Detailed description:

Arms:
arm 1: Arm 1: drug arm 2: Arm 2: active comparator

Interventions: intervention 1: sitagliptin phosphate (+) metformin hydrochloride intervention 2: metformin
Intervention descriptions: intervention 1: sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period. intervention 2: metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Protocol document: