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

Primary Purpose

Renal Impairment, Diabetes

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

Vildagliptin

About this trial

This is an interventional treatment trial for Renal Impairment focused on measuring Renal impairment, Diabetes, vildagliptin, Galvus, Eucreas

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Vildagliptin 25 mg qd in Renal Impaired (RI) patients

Vildagliptin 50 mg qd in RI Patients

Vildagliptin 25 mg qd in matched Healthy Volunteer (HV)

Vildagliptin 50 mg qd in matched HV

Arm Description

Outcomes

Primary Outcome Measures

Measure: pharmacokinetics of vildagliptin and its metabolites

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00818571

First Posted

January 6, 2009

Last Updated

December 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00818571

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment, Diabetes

Keywords

Renal impairment, Diabetes, vildagliptin, Galvus, Eucreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vildagliptin 25 mg qd in Renal Impaired (RI) patients

Arm Type

Experimental

Arm Title

Vildagliptin 50 mg qd in RI Patients

Arm Type

Experimental

Arm Title

Vildagliptin 25 mg qd in matched Healthy Volunteer (HV)

Arm Type

Experimental

Arm Title

Vildagliptin 50 mg qd in matched HV

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Intervention Description

Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Intervention Description

Matching healthy volunteers receiving 25 mg vildagliptin once daily.

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Intervention Description

Matching healthy volunteers receiving 50 mg vildagliptin once daily

Primary Outcome Measure Information:

Title

Measure: pharmacokinetics of vildagliptin and its metabolites

Time Frame

14 days

Secondary Outcome Measure Information:

Title

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

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigator Site

City

Moscow

Country

Russian Federation

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2949

Description

Results for CLAF237B2202 from the Novartis Clinical Trials website

Learn more about this trial

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

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