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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 glimepiride 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental |
| |
| Glimepiride | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug |
|
| |
| glimepiride |
| Measure | Description | Time Frame |
|---|---|---|
| Time to HbA1c >8% | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at 5 years | 2 years (amended) | |
| Adverse event profile after 5 years of treatment | 2 years (amended) | |
| Coefficient of failure for HbA1c from week 24 to 5 years |
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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 |
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| Label | URL |
|---|---|
| Results for CLAF237A2308 from the Novartis Clinical Trials website | View source |
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| Drug |
|
| Metformin | Drug |
|
| Vildagliptin matching placebo | Drug |
|
| Glimepiride matching placebo | Drug |
|
| 2 years (amended) |
| Change from baseline in fasting plasma glucose at 5 years | 2 years (amended) |
| Change from baseline in body weight at 5 years | 2 years (amended) |
| Nuremberg |
| Germany |
| 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 |
| C475520 | 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine |
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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