Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

• Status: Completed
• Trial end date: 2006-05-01
• 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 assess the 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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• Blood glucose criteria must be met

• Not currently on drug therapy for type 2 diabetes

• Body mass index (BMI) in the range 22-45

• Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion Criteria:

• Pregnancy or lactation

• Type 1 diabetes

• Evidence of serious diabetic complications

• Evidence of serious cardiovascular complications

• Significant laboratory abnormalities as defined by the protocol

• Other protocol-defined exclusion criteria may apply