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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2010-021097-11 |
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This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin (metformin + glimepiride) | Experimental |
| |
| Placebo (metformin + glimepiride) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Reduction | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| FPG reduction | 24 weeks | |
| Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs) | 24 weeks |
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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 Investigative Site | Box Hill | Australia | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24199686 | Result | Lukashevich V, Del Prato S, Araga M, Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014 May;16(5):403-9. doi: 10.1111/dom.12229. Epub 2013 Dec 2. |
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|
| Responder Rate | 24 weeks |
| Heidelberg |
| Australia |
| Novartis Investigative Site | Parkville | Australia |
| Novartis Investigative Site | St Leonards | Australia |
| Novartis Investigative Site | Anderbeck | Germany |
| Novartis Investigative Site #1 | Berlin | Germany |
| Novartis Investigative Site #2 | Berlin | Germany |
| Novartis Investigative Site #3 | Berlin | Germany |
| Novartis Investigative Site #4 | Berlin | Germany |
| Novartis Investigative Site | Hamburg | Germany |
| Novartis Investigative Site | Hildesheim | Germany |
| Novartis Investigative Site | Sangerhausen | Germany |
| Novartis Investigative Site | Budapest | Hungary |
| Novartis Investigative Site | Érd | Hungary |
| Novartis Investigative Site | Törökbálint | Hungary |
| Novartis Investigative Site | Bergamo | Italy |
| Novartis Investigative Site | Cosenza | Italy |
| Novartis Investigative Site | Milan | Italy |
| Novartis Investigative Site | Padova | Italy |
| Novartis Investigative Site | Pisa | Italy |
| Novartis Investigative Site #1 | Roma | Italy |
| Novartis Investigative Site #2 | Roma | Italy |
| Novartis Investigative Site | Torino | Italy |
| Novartis Investigative Site #1 | Aguascalientes | Mexico |
| Novartis Investigative Site #2 | Aguascalientes | Mexico |
| Novartis Investigative Site #3 | Aguascalientes | Mexico |
| Novartis Investigative Site #1 | Durango | Mexico |
| Novartis Investigative Site #2 | Durango | Mexico |
| Novartis Investigative Site #3 | Durango | Mexico |
| Novartis Investigative Site #1 | Guadalajara | Mexico |
| Novartis Investigative Site #2 | Guadalajara | Mexico |
| Novartis Investigative Site #3 | Guadalajara | Mexico |
| Novartis Investigative Site #4 | Guadalajara | Mexico |
| Novartis Investigative Site #5 | Guadalajara | Mexico |
| Novartis Investigative Site | México | Mexico |
| Novartis Investigative Site #1 | Pachuca | Mexico |
| Novartis Investigative Site #2 | Pachuca | Mexico |
| Novartis Investigative Site #3 | Pachuca | Mexico |
| Novartis Investigative Site | Manila | Philippines |
| Novartis Investigative Site #1 | Quezon City | Philippines |
| Novartis Investigative Site #2 | Quezon City | Philippines |
| Novartis Investigative Site | Alba Iulia | Romania |
| Novartis Investigative Site | Bucharest | Romania |
| Novartis Investigative Site #1 | Oradea | Romania |
| Novartis Investigative Site #2 | Oradea | Romania |
| Novartis Investigative Site | Târgu Mureş | Romania |
| Novartis Investigative Site | Bundang | South Korea |
| Novartis Investigative Site #1 | Seoul | South Korea |
| Novartis Investigative Site #2 | Seoul | South Korea |
| Novartis Investigative Site #3 | Seoul | South Korea |
| Novartis Investigative Site | Suwon | South Korea |
| Novartis Investigative Site | Changhua | Taiwan |
| Novartis Investigative Site | Taichung | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan |
| Novartis Investigative Site | Yongkang District | Taiwan |
| 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 |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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