Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.

This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Inclusion Criteria:

• Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
• Agreement to maintain the same dose of metformin from screening to the end of the study
• Age in the range of 18-80 years
• Body mass index (BMI) in the range of 22-40 kg/m2
• HbA1c in the range of 7.0 to 10%
• FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

• A history of type 1 diabetes
• Liver disease
• Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply