Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

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

Summary

This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 2,4-thiazolidinedione; Metformin; Pioglitazone; Rosiglitazone; Vildagliptin

Criteria

Inclusion Criteria:

• Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)

• Agreement to maintain the same dose of metformin from screening to the end of the study

• Age in the range of 18-80 years

• Body mass index (BMI) in the range of 22-40 kg/m2

• HbA1c in the range of 7.0 to 10%

• FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

• A history of type 1 diabetes

• Liver disease

• Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply