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Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event profile after 52 weeks of treatment | ||
| Change from baseline in fasting plasma glucose at 52 weeks | ||
| Change from baseline in body weight 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 | ||
| Investigative Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18034842 | Result | Bolli G, Dotta F, Rochotte E, Cohen SE. Efficacy and tolerability of vildagliptin vs. pioglitazone when added to metformin: a 24-week, randomized, double-blind study. Diabetes Obes Metab. 2008 Jan;10(1):82-90. doi: 10.1111/j.1463-1326.2007.00820.x. Epub 2007 Nov 22. |
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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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| Patients with endpoint HbA1c < 7% after 52 weeks |
| Patients with reduction in HbA1c >/= to 7% after 52 weeks |
| Nuremberg |
| Germany |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |