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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Renal Impairment; Diabetes

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818571

2008-004565-25 (EudraCT Number)

CLAF237B2202

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 4 patient groups

Vildagliptin 25 mg qd in Renal Impaired (RI) patients

Experimental group

Treatment:

Drug: Vildagliptin

Drug: Vildagliptin

Drug: Vildagliptin

Drug: Vildagliptin

Vildagliptin 50 mg qd in RI Patients

Experimental group

Treatment:

Drug: Vildagliptin

Drug: Vildagliptin

Drug: Vildagliptin

Drug: Vildagliptin

Vildagliptin 25 mg qd in matched Healthy Volunteer (HV)

Experimental group

Treatment:

Drug: Vildagliptin

Drug: Vildagliptin

Drug: Vildagliptin

Drug: Vildagliptin

Vildagliptin 50 mg qd in matched HV

Experimental group

Treatment:

Drug: Vildagliptin

Drug: Vildagliptin

Drug: Vildagliptin

Drug: Vildagliptin