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

Sponsor

Novartis (Industry)

Overall Status

Terminated

CT.gov ID

NCT00633997

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin Drug: Vildagliptin	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Healthy volunteers	Drug: Vildagliptin 50 mg orally twice daily for 10 days (last dose morning of day 10) Other Names: LAF237 Galvus
Experimental: 2 Type II diabetics	Drug: Vildagliptin

Arm

Intervention/Treatment

Experimental: 1

Healthy volunteers

Drug: Vildagliptin

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

Other Names:

LAF237 Galvus

Experimental: 2

Type II diabetics

Drug: Vildagliptin

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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