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

Stopped early · Phase 1/Phase 2

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00633997

Run by

Novartis

People needed

22

Starts

2008-02-01

Last updated by the study team

2020-12-17

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigator Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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