Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. 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

Details

• Lead Sponsor: Novartis
• Treatments: Rosiglitazone; Vildagliptin

Criteria

Inclusion Criteria:

• Only patients successfully completing study CLAF237A2327 are eligible

• Written informed consent

• Ability to comply with all study requirements

Exclusion Criteria:

• Premature discontinuation from study CLAF237A2327

• Other protocol-defined exclusion criteria may apply