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After analysis of the existing data, it was determined that additional skin biopsy samples would not be required to determine study outcome.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Healthy volunteers |
|
| 2 | Experimental | Type II diabetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | 50 mg orally twice daily for 10 days (last dose morning of day 10) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Baltimore | Maryland | 21225 | United States |
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| Label | URL |
|---|---|
| Results for CLAF237A2224 from the Novartis Clinical Trials website | View source |
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| Vildagliptin | Drug |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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