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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00818571

Enrollment

Registered

2009-01-07

Start date

2008-12-31

Completion date

Unknown

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Renal Impairment

Keywords

Renal impairment, Diabetes, vildagliptin, Galvus, Eucreas

Brief summary

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

Interventions

DRUGVildagliptin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
Measure: pharmacokinetics of vildagliptin and its metabolites	14 days

Secondary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026