Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients who sign the informed consent

• HbA1c in the range of > 7 to ≤10.5% at Visit 1

• Ability to comply with all study requirements

Exclusion Criteria:

• Pregnant or lactating women

• Serious cardiovascular disorders

• Liver/renal disease or dysfunction

• Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin

• Laboratories values abnormalities as defined by the protocol