Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
- Registration Number
- NCT00633997
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Vildagliptin Type II diabetics 1 Vildagliptin Healthy volunteers
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Trial Locations
- Locations (1)
Novartis Investigator Site
🇺🇸Baltimore, Maryland, United States