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The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in the treatment of type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vildagliptin | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Fasting Plasma Glucose | 24 weeks | |
| Safety and tolerability (Frequency of adverse events, serious adverse events, and notable laboratory abnormalities) of add-on therapy with vildagliptin 50 mg qd to glimepiride as compared to pbo |
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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 Investigative Site | Beijing | Beijing Municipality | 100088 | China | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24823599 | Derived | Yang W, Xing X, Lv X, Li Y, Ma J, Yuan G, Sun F, Wang W, Woloschak M, Lukashevich V, Kozlovski P, Kothny W; all investigators. Vildagliptin added to sulfonylurea improves glycemic control without hypoglycemia and weight gain in Chinese patients with type 2 diabetes mellitus. J Diabetes. 2015 Mar;7(2):174-81. doi: 10.1111/1753-0407.12169. Epub 2014 Jul 29. |
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|
| 24 weeks |
| Responder rates - proportion of subjects reaching predefined HbA1c targets | 24 weeks |
| Shijiazhuang |
| Hebei |
| 050051 |
| China |
| Novartis Investigative Site | Wuhan | Hubei | 430070 | China |
| Novartis Investigative Site | Changsha | Hunan | 410003 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210006 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210008 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210029 | China |
| Novartis Investigative Site | Zhenjiang | Jiangsu | 212001 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110003 | China |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | China |
| Novartis Investigative Site | Tianjin | Tianjin Municipality | 300211 | China |
| Novartis Investigative Site | Beijing | 100029 | China |
| Novartis Investigative Site | Beijing | 100034 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Beijing | China |
| Novartis Investigative Site | Guangzhou | 510080 | China |
| Novartis Investigative Site | Shanghai | 200040 | China |
| Novartis Investigative Site | Shanghai | 200233 | 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 |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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