Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.

• HbA1c in the range of 7.0-10.0%

• Body mass index in the range 20-35 kg/m2

Exclusion Criteria:

• Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes

• Significant heart diseases

Other protocol-defined inclusion/exclusion criteria may apply