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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 6, 2009
Last updated: January 12, 2016
Last verified: January 2016
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients

Condition Intervention Phase
Renal Impairment
Drug: Vildagliptin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: pharmacokinetics of vildagliptin and its metabolites [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Measure: safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 14 days ]

Enrollment: 96
Study Start Date: December 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00818571

Russian Federation
Novartis Investigator Site
Moscow, Russian Federation
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00818571     History of Changes
Other Study ID Numbers: CLAF237B2202
2008-004565-25 ( EudraCT Number )
Study First Received: January 6, 2009
Last Updated: January 12, 2016

Keywords provided by Novartis:
Renal impairment

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 22, 2017