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This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vildagliptin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in disposition index at 52 weeks | 52 weeks | |
| Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks | 52 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | Basel | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21547496 | Derived | Foley JE, Bunck MC, Moller-Goede DL, Poelma M, Nijpels G, Eekhoff EM, Schweizer A, Heine RJ, Diamant M. Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial. Diabetologia. 2011 Aug;54(8):1985-91. doi: 10.1007/s00125-011-2167-8. Epub 2011 May 6. |
| Label | URL |
|---|---|
| Results for CLAF237A2381 on the Novartis clinical trials website | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks |
| 52 weeks |
| Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks | 52 weeks |
| Beta-cell function parameter derived from standard meal challenge | 52 weeks |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |