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

Condition(s): Renal Impairment Diabetes
NCTId: NCT00818571

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

Summary

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

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years 75 Years True

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

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

Vildagliptin - Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
Vildagliptin - Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
Vildagliptin - Matching healthy volunteers receiving 25 mg vildagliptin once daily.
Vildagliptin - Matching healthy volunteers receiving 50 mg vildagliptin once daily

Study Outcomes

Primary Outcome(s)

Timeframe: 14 days
Measure: Measure: pharmacokinetics of vildagliptin and its metabolites
Safety Issue? No

Secondary Outcome(s)

Measure: Measure: safety assessments will include vital signs, electrocardiograms and adverse events
Timeframe: 14 days
Safety Issue? Yes

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations

Novartis Investigator Site
Moscow, Russian Federation

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Renal Impairment
  2. Diabetes

Other Related Condition Keywords

  1. Diabetes Mellitus
  2. Renal Insufficiency

Related Intervention Keywords

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