Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.

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

Details

• Lead Sponsor: Novartis
• Treatments: Metformin; Vildagliptin

Criteria

Inclusion Criteria:

• Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1

• Agreement to maintain the same dose of metformin from randomization to the end of the study

• Age in the range of 18-78 years inclusive

• Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1

• HbA1c in the range of > 7.0 to ≤10% at Visit 1

• Agreement to maintain prior diet and exercise habits during the full course of the study

• Ability to comply with all study requirements

Exclusion Criteria:

• Fasting Plasma Glucose (FPG) > 270 mg/dl (15 mmol/L) at Visit 1

• Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply