Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes

An Open-label, Multiple Dose Study to Assess the Steady-state Skin Concentrations and Pharmacokinetics of Vildagliptin 50 mg BID for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00633997

Enrollment

Registered

2008-03-12

Start date

2008-02-29

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 Mellitus, Type 2

Keywords

Diabetes mellitus, type 2 diabetes, vildagliptin, pharmacokinetics

Brief summary

This study will look at the skin accumulation of vildagliptin and its two major metabolites, LAY151 and LAF237-O-Glucuronide, after vildagliptin 50 mg given orally twice a day for 10 days in both healthy volunteers and patients with type 2 diabetes.

Interventions

DRUGVildagliptin

50 mg orally twice daily for 10 days (last dose morning of day 10)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers and patients with type 2 diabetes * Non-smoking, Caucasian and African American, male and female (postmenopausal, surgically sterile or using double-barrier method of contraception) subjects between 30 and 65 years of age (inclusive) * Type 2 diabetics on metformin and/or sufonylurea

Exclusion criteria

* History of type 1 diabetes or insulin use * History of coagulation abnormalities * History of abnormal heart conditions * Pregnancy or breastfeeding Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Skin concentration of vildagliptin and its two metabolites, LAY151 and LAF237-O-Glucuronide, compared to the plasma concentration on Day 10	Baseline (Day -1) to End of Study (Day 17 +/- 2 days)

Secondary

Measure	Time frame
10 day's treatment with vildagliptin 50 mg orally twice daily on hematology, blood chemistry and physical exams in healthy volunteers and patients with type 2 diabetes	Baseline (Day -1) to End of study (Day 17 +/- 2 days)

Countries

United States

Outcome results

None listed

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