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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00818571
First received: January 6, 2009
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group 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 ] [ Designated as safety issue: No ]

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

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 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 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818571

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00818571     History of Changes
Other Study ID Numbers: CLAF237B2202, 2008-004565-25
Study First Received: January 6, 2009
Last Updated: September 23, 2010
Health Authority: Russia: Ministry of Health of the Russian Federation
United States: Food and Drug Administration

Keywords provided by Novartis:
Renal impairment
Diabetes
vildagliptin
Galvus
Eucreas

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014