Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients

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

Summary

This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to <50 ml/min) and severe (CrCl of <30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of >80 ml/min

Exclusion Criteria:

• Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history

Other protocol-defined inclusion/exclusion criteria may apply