A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

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

Summary

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.

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

Details

• Lead Sponsor: Novartis
• 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 type 2 diabetes for at least 4 weeks prior to study entry

• Body mass index 22-40 kg/meter squared

• HbA1c > 11% and/or FPG >270 mg/dL

Exclusion Criteria:

• Pregnant or lactating female

• History of type 1 diabetes

• Evidence of significant diabetic complications

• Treatment with insulin or any other oral antidiabetic agent

Other protocol-defined inclusion/exclusion criteria may apply.