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The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin Dose 1 | Experimental |
| |
| Vildagliptin Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin 50 mg bid | Drug |
| ||
| Vildagliptin 50 mg qd |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c after 24 weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients with HbA1c < 7% after 24 weeks | 24 weeks | |
| Adverse event profile after 24 weeks of treatment | 24 weeks | |
| Change from baseline in fasting plasma glucose at 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 |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | China | ||||
| General Hospital of Beijing Military Region of PLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22369287 | Result | Pan C, Xing X, Han P, Zheng S, Ma J, Liu J, Lv X, Lu J, Bader G; Institution Investigators. Efficacy and tolerability of vildagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012 Aug;14(8):737-44. doi: 10.1111/j.1463-1326.2012.01593.x. Epub 2012 Apr 1. |
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|
| Placebo | Drug |
|
| 24 weeks |
| Beijing |
| China |
| Peking Union Medical College Hospital | Beijing | China |
| Peking University First Hospital | Beijing | China |
| The General Hospital of the PLA | Beijing | China |
| The General Hospital of the Second Artilleryman of PLA | Beijing | China |
| The Affiliated Union Hospital of Fujian Medical University | Fuzhou | China |
| The Fuzhou General Hospital of the PLA Nanjing Military Area | Fuzhou | China |
| Guangdong Provincial People's Hospital | Guangzhou | China |
| Second Affiliated Hospital of Nanchang University | Nanchang | China |
| The Jiangxi Provincial People's Hospital | Nanchang | China |
| Te Affiliated Drum Tower of Nanjing University Medical School | Nanjing | China |
| Tongji Hospital of Tongji University | Nanjing | China |
| Shanghai Changzheng Hospital | Shanghai | China |
| The Second Affiliated Hospital of China Medical University | Shenyang | China |
| The Second Affiliated Hospital of Tianjin Medical University | Tianjin | China |
| First Affiliated Hospital of 4th Military Medical University | Xi'an | China |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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