Status:
TERMINATED
Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
Lead Sponsor:
Novartis
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
PHASE2
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 heal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00633997
Start Date
February 1 2008
Last Update
December 17 2020
Active Locations (1)
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1
Novartis Investigator Site
Baltimore, Maryland, United States, 21225