Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

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

Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. 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: Pioglitazone; Vildagliptin

Criteria

Inclusion Criteria:

• Only patients successfully completing study CLAF237A2304 are eligible

• Written informed consent

• Ability to comply with all study requirements

Exclusion Criteria:

• Premature discontinuation from study CLAF237A2304

• Other protocol-defined exclusion criteria may apply