Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was not conducted in the United States. The purpose of this study was 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.

• 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

Exclusion Criteria:

• Pregnancy or lactation

• Type 1 diabetes

• Evidence of serious diabetic complications

• Evidence of serious cardiovascular conditions

• Laboratory value abnormalities as defined by the protocol

• Other protocol-defined exclusion criteria may apply