Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 744
Healthy volunteers: no

Brief summary:
This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

Detailed description:

Arms:
arm 1: Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks. arm 2: Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks. arm 3: Metformin 500 mg twice daily for 24 weeks. arm 4: Metformin 850 mg twice daily for 24 weeks. arm 5: Sitagliptin 100 mg once daily for 24 weeks. arm 6: Matching placebo tablets for 24 weeks.

Interventions: intervention 1: Sitagliptin 50 mg intervention 2: Metformin 500 mg intervention 3: Sitagliptin 100 mg intervention 4: Placebo intervention 5: Metformin 850 mg
Intervention descriptions: intervention 1: Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks. intervention 2: Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks. intervention 3: Sitagliptin 100 mg once daily for 24 weeks. intervention 4: Matching placebo tablets to sitagliptin or metformin for 24 weeks. intervention 5: Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.

Protocol document: