Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes

Inclusion Criteria:

• Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
• Diagnosis of T2DM for at least 4 weeks prior to study entry
• Age 18 - 78 years inclusive
• Body mass index (BMI) of 22 - 40 kg/m2
• HbA1c: 7.5 - 11% inclusive
• FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria

• Pregnant or lactating female
• A history of type 1 diabetes
• Evidence of significant diabetic complications
• Other protocol-defined inclusion/exclusion criteria may apply