Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well 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 the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

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

Details

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

Criteria

Inclusion Criteria:

• 18-78 years inclusive

• Type 2 diabetes diagnosis at least 2 months prior to study entry

• Body mass index in the range of 22-45 kg/m2

• HbA1c in the range of 6.5 to 9% inclusive

• Fasting plasma glucose <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

• Congestive heart failure requiring pharmacologic treatment

• Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply