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Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of vildagliptin in combination with insulin during 52 weeks of treatment | ||
| Change from baseline in HbA1c at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c between 24 weeks and 52 weeks | ||
| Change in fasting plasma glucose between 24 weeks and 52 weeks | ||
| Change from baseline in fasting plasma glucose at 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 | East Hanover | New Jersey | 07936 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18401832 | Result | Fonseca V, Baron M, Shao Q, Dejager S. Sustained efficacy and reduced hypoglycemia during one year of treatment with vildagliptin added to insulin in patients with type 2 diabetes mellitus. Horm Metab Res. 2008 Jun;40(6):427-30. doi: 10.1055/s-2008-1058090. Epub 2008 Mar 11. No abstract available. |
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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 from baseline in mean daily insulin dose at 52 weeks |
| Change from baseline in mean daily number of insulin injections at 52 weeks |
| Investigative Centers |
| Germany |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |