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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00818571

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment Diabetes	Drug: Vildagliptin Drug: Vildagliptin Drug: Vildagliptin Drug: Vildagliptin	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin 25 mg qd in Renal Impaired (RI) patients	Drug: Vildagliptin Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
Experimental: Vildagliptin 50 mg qd in RI Patients	Drug: Vildagliptin Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
Experimental: Vildagliptin 25 mg qd in matched Healthy Volunteer (HV)	Drug: Vildagliptin Matching healthy volunteers receiving 25 mg vildagliptin once daily.
Experimental: Vildagliptin 50 mg qd in matched HV	Drug: Vildagliptin Matching healthy volunteers receiving 50 mg vildagliptin once daily

Outcome Measures

Primary Outcome Measures

Measure: pharmacokinetics of vildagliptin and its metabolites [14 days]

Secondary Outcome Measures

Measure: safety assessments will include vital signs, electrocardiograms and adverse events [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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