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

Novartis

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633997

CLAF237A2224

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

1

Experimental group

Description:

Healthy volunteers

Treatment:

Drug: Vildagliptin

Drug: Vildagliptin

2

Experimental group

Description:

Type II diabetics

Treatment:

Drug: Vildagliptin

Drug: Vildagliptin