Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients
- Registration Number
- NCT00818571
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vildagliptin 25 mg qd in Renal Impaired (RI) patients Vildagliptin - Vildagliptin 50 mg qd in RI Patients Vildagliptin - Vildagliptin 25 mg qd in matched Healthy Volunteer (HV) Vildagliptin - Vildagliptin 50 mg qd in matched HV Vildagliptin -
- Primary Outcome Measures
Name Time Method Measure: pharmacokinetics of vildagliptin and its metabolites 14 days
- Secondary Outcome Measures
Name Time Method Measure: safety assessments will include vital signs, electrocardiograms and adverse events 14 days
Trial Locations
- Locations (1)
Novartis Investigator Site
🇷🇺Moscow, Russian Federation