Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. The purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.

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

Details

• Lead Sponsor: Novartis
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• Only patients successfully completing study CLAF237A2329 are eligible

• Written informed consent

• HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units

• Ability to comply with all study requirements

Exclusion Criteria:

• Premature discontinuation from study CLAF237A2329

• Other protocol-defined exclusion criteria may apply