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

• Status: Completed
• Trial end date: 2008-06-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Metformin; Vildagliptin

Criteria

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