NCT00728351
Completed
Phase 3
A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.
ConditionsDiabetes Mellitus, Type 2
Overview
- Phase
- Phase 3
- Intervention
- vildagliptin + metformin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 317
- Locations
- 45
- Primary Endpoint
- HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •History of T2DM treated with Metformin
Exclusion Criteria
- •FPG \>= 260 mg/dL (14.4mmol/L)
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
vildagliptin + metformin
Intervention: vildagliptin + metformin
metformin
Intervention: metformin
Outcomes
Primary Outcomes
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
Time Frame: 24 weeks
Secondary Outcomes
- Body weight change from baseline(24 weeks)
- Safety and tolerability(24 weeks)
- FPG reduction(24 weeks)
- Changes in the fasting lipid profile(24 weeks)
Study Sites (45)
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