Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Glucagon; Vildagliptin

Criteria

Inclusion Criteria:

• Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for > 3 consecutive months

• >/= 18 years

• Body mass index in the range of 22-35 kg/m2

• HbA1c Exclusion Criteria:

• Type 1 diabetes

• Acute metabolic diabetic complications

• Evidence of significant diabetic complications

• Insulin treatment within the past 6 months

Other protocol-defined inclusion/exclusion criteria may apply