Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy

• Age in the 20 years or over inclusive

• HbA1c in the range of ≥ 6.5 to ≤ 10%

Exclusion Criteria:

• Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes

• Significant heart diseases

• Significant diabetic complications