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Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vildagliptin am | Experimental |
| |
| vildagliptin pm | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin AM | Drug |
| ||
| vildagliptin pm |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at 24 weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of vildagliptin in combination with metformin during 24 weeks of treatment | 24 weeks | |
| Change from baseline in fasting plasma glucose at 24 weeks | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19221978 | Result | Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16. |
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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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|
| placebo | Drug |
|
| Patients with endpoint HbA1c < 7% after 24 weeks |
| 24 weeks |
| Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks | 24 weeks |
| Change from baseline in body weight at 24 weeks | 24 weeks |
| Investigative Centers |
| Germany |
| D004700 | Endocrine System Diseases |