Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

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

Details

• Lead Sponsor: Novartis
• Treatments: Insulin; Vildagliptin

Criteria

Inclusion Criteria:

• Confirmed diagnosis of T2DM

• On a stable dose of insulin as defined by the protocol

• On a stable does of metformin (if applicable) as defined by the protocol

• Age 18 to 80 years

• HbA1c of 7.5 to 11.0%

• Body Mass Index (BMI) 22 to 40 kg/m2

Exclusion Criteria:

• Type 1 diabetes

• Short-acting or rapid-acting insulin

• Pregnancy or lactation

• Evidence of serious diabetic complications

• Evidence of serious cardiovascular complications

• Laboratory value abnormalities as defined by the protocol

• Other protocol-defined inclusion/exclusion criteria may apply