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The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin + Metformin Dose 1 | Experimental |
| |
| Vildagliptin + Metformin Dose 2 | Experimental |
| |
| Vildagliptin | Active Comparator |
| |
| Metformin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug |
| ||
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | At week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in fasting plasma glucose | At week 24 | |
| Percent of patients with endpoint HbA1c <7% | At week 24 | |
| Percent of patients with reduction in HbA1c >/=0.7% |
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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 | ||
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| Label | URL |
|---|---|
| Clinical Trial Results for CLMF237A2302 at Novartis Clinical Trials.com | View source |
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|
| Vildagliptin + Metformin | Drug |
|
| At week 24 |
| Adverse event profile after treatment | At week 24 |
| Change from baseline in body weight | At week 24 |
| 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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