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This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at 108 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event profile after 108 weeks of treatment | ||
| Change in HbA1c from week 52 to week 108 | ||
| Change from baseline in fasting plasma glucose at week 108 |
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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 |
|---|---|---|---|---|---|---|
| Investigative Sites | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18355325 | Derived | Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Wang Y, Dunning BE, Foley JE. Evidence that vildagliptin attenuates deterioration of glycaemic control during 2-year treatment of patients with type 2 diabetes and mild hyperglycaemia. Diabetes Obes Metab. 2008 Nov;10(11):1114-24. doi: 10.1111/j.1463-1326.2008.00875.x. Epub 2008 Mar 18. |
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| Change in fasting plasma glucose from week 52 to week 108 |
| Change from baseline in body weight at week 108 |
| 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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