Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Incretins; Metformin; Vildagliptin

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks

• Agreement to maintain the same dose of metformin throughout the study

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

• HbA1c in the range of 7.0 to 9.0%

• FPG <200 mg/dl (11.1 mmol/L)

• Agreement to maintain prior diet and exercise habits during the full course of the study

• Ability to comply with all study requirements and signed informed consent to participate in the study

Exclusion Criteria:

• A history of type 1 diabetes

• A history of acute metabolic diabetic complications

• Evidence of significant diabetic complications

• Insulin treatment for longer than 10 days within the past 6 months

• Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Other protocol-defined inclusion/exclusion criteria may apply