Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes

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

Summary

The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• Not currently on drug therapy for type 2 diabetes

• Blood glucose criteria must be met

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

Exclusion Criteria:

• History of type 1 diabetes

• Evidence of significant diabetic complications

• Serious cardiovascular events within the past 6 months

• Laboratory value abnormalities as defined by the protocol

• Other protocol-defined exclusion criteria may apply