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This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Vildagliptin 100 mg qd |
|
| 2 | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug | vildagliptin 100 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-peptide IAUC (0-4hr) | 2 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin secretion rate (ISR) relative to glucose (0-2hr) | after 2 weeks of treatment | |
| Change in postprandial C-peptide | after two weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Zentrum Bad Lauterberg | Bad Lauterberg im Harz | 37431 | Germany | |||
| Novartis Pharmaceuticals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21239518 | Result | Vardarli I, Nauck MA, Kothe LD, Deacon CF, Holst JJ, Schweizer A, Foley JE. Inhibition of DPP-4 with vildagliptin improved insulin secretion in response to oral as well as "isoglycemic" intravenous glucose without numerically changing the incretin effect in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011 Apr;96(4):945-54. doi: 10.1210/jc.2010-2178. Epub 2011 Jan 14. |
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| Placebo |
| Drug |
matching placebo |
|
| Change in postprandial insulin |
| after two weeks of treatment |
| Change in postprandial glucagon | after two weeks of treatment |
| Change in postprandial GLP-1 | after 2 weeks of treatment |
| Basel |
| Switzerland |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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