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Completed

NCT Number: NCT00818571

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

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

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Key information

Conditions

Renal Impairment Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigator Site

Moscow, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin

Drug

Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily

Primary outcomes

  1. Measure: pharmacokinetics of vildagliptin and its metabolites

    Time frame: 14 days

Secondary outcomes

  1. Measure: safety assessments will include vital signs, electrocardiograms and adverse events

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
First posted
Jan 7, 2009
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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