Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients 18-78 years old inclusive at Visit 1

• T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1

• Patient agreement to maintain same dose of metformin throughout study

• HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1

• Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Exclusion Criteria:

• Pregnant or nursing (lactating) women

• FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)