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

Phase 2TerminatedNCT00633997

Novartis22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

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

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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/exclusion criteria may apply

Locations (1)

Novartis Investigator Site

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Skin concentration of vildagliptin and its two metabolites, LAY151 and LAF237-O-Glucuronide, compared to the plasma concentration on Day 10

Time frame: Baseline (Day -1) to End of Study (Day 17 +/- 2 days)

Secondary Outcomes

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

Time frame: Baseline (Day -1) to End of study (Day 17 +/- 2 days)

Data from ClinicalTrials.gov

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