A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

• Status: Completed
• Trial end date: 2007-06-26
• Target enrollment: 0
• Participant gender: All

Summary

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• Completion of study CLAF237A2307 within 4 weeks of entering into the extension

• Written informed consent

• Ability to comply with all study requirements

• Blood glucose criteria must be met

Exclusion Criteria:

• Premature discontinuation from study CLAF237A2307