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This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vildagliptin + metformin | Experimental |
| |
| Metformin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug |
| ||
| metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event profile after 24 weeks of treatment | 24 weeks | |
| Gastrointestinal tolerability after 24 weeks of treatment | 24 weeks | |
| Patients with endpoint HbA1c <7% and <6.5% after 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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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 |
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| Label | URL |
|---|---|
| Results for CLAF237A23104 from the Novartis Clinical Trials website | View source |
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|
| 24 weeks |
| Patients with reduction in HbA1c >0.7% after 24 weeks | 24 weeks |
| Change from baseline in fasting plasma glucose after 24 weeks | 24 weeks |
| Multiple Locations |
| 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 |
| 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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