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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
744
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Sitagliptin 100 mg once daily for 24 weeks.
Change From Baseline in Hemoglobin A1C (A1C) at Week 24
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Time frame: Baseline and Week 24
Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24
Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.
Time frame: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
Time frame: Baseline and Week 24
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Matching placebo tablets to sitagliptin or metformin for 24 weeks.
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.