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

December 11, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure: pharmacokinetics of vildagliptin and its metabolites
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure: safety assessments will include vital signs, electrocardiograms and adverse events
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237B2202
  • 2008-004565-25 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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