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This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental |
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| Treatment Sequence 2 | Experimental |
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| Treatment Sequence 3 | Experimental |
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| Treatment Sequence 4 | Experimental |
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| Treatment Sequence 5 | Experimental |
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| Treatment Sequence 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin (LAF237) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of vildagliptin | Up to 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon) | Up to 4 hours or 12 hours post-dose |
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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 Investigative Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23782587 | Result | Yamaguchi M, Saji T, Mita S, Kulmatycki K, He YL, Furihata K, Sekiguchi K. Pharmacokinetic and pharmacodynamic interaction of vildagliptin and voglibose in Japanese patients with Type 2 diabetes. Int J Clin Pharmacol Ther. 2013 Aug;51(8):641-51. doi: 10.5414/CP201902. |
| Label | URL |
|---|---|
| Results for CLAF237A1103 from 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 |
| C475520 | 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine |
| C102817 | voglibose |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Voglibose | Drug |
|
| Vildagliptin and Voglibose | Drug |
|
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |