Status:
COMPLETED
Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Impairment
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00818571
Start Date
December 1 2008
Last Update
December 17 2020
Active Locations (1)
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1
Novartis Investigator Site
Moscow, Russia