Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

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

Summary

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

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

Details

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

Criteria

Inclusion Criteria:

• Age from 65 years to the upper age limit recommended by local prescribing information for metformin

• Drug naive patients with type 2 diabetes.

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

• HbA1c in the range of 7 to 9% inclusive

• FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

• A history of type 1 diabetes

• Evidence of significant diabetic complications

• Treatment with insulin or any other oral antidiabetic agents

Other protocol-defined inclusion/exclusion criteria may apply