This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
914
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Novartis Investigative Site
Multiple Locations, Germany
Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment
Time frame: 24 weeks
Adverse event profile after 24 weeks of treatment
Time frame: 24 weeks
Gastrointestinal tolerability after 24 weeks of treatment
Time frame: 24 weeks
Patients with endpoint HbA1c <7% and <6.5% after 24 weeks
Time frame: 24 weeks
Patients with reduction in HbA1c >0.7% after 24 weeks
Time frame: 24 weeks
Change from baseline in fasting plasma glucose after 24 weeks
Time frame: 24 weeks
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