NCT00818571

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Last Updated

December 17, 2020

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

January 6, 2009

Last Update Submit

December 11, 2020

Conditions

Renal ImpairmentDiabetes

Keywords

Renal impairmentDiabetesvildagliptinGalvusEucreas

Outcome Measures

Primary Outcomes (1)

  • Measure: pharmacokinetics of vildagliptin and its metabolites

    14 days

Secondary Outcomes (1)

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

    14 days

Study Arms (4)

Vildagliptin 25 mg qd in Renal Impaired (RI) patients

EXPERIMENTAL
Drug: Vildagliptin

Vildagliptin 50 mg qd in RI Patients

EXPERIMENTAL
Drug: Vildagliptin

Vildagliptin 25 mg qd in matched Healthy Volunteer (HV)

EXPERIMENTAL
Drug: Vildagliptin

Vildagliptin 50 mg qd in matched HV

EXPERIMENTAL
Drug: Vildagliptin

Interventions

VildagliptinDRUG

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

Vildagliptin 25 mg qd in Renal Impaired (RI) patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigator Site

Moscow, Russia

Location

Related Links

MeSH Terms

Conditions

Renal InsufficiencyDiabetes Mellitus

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

December 1, 2008

Primary Completion

May 1, 2009

Last Updated

December 17, 2020

Record last verified: 2016-01

Locations

RU(1)