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To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.
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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 |
|---|---|---|
| HbA1c reduction | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c reduction in subpopulation treated with insulin and with metformin | 24 weeks | |
| HbA1c reduction in subpopulation treated with insulin and without metformin | 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Box Hill | Australia | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23961326 | Result | Kozlovski P, Foley J, Shao Q, Lukashevich V, Kothny W. Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):151-6. doi: 10.4239/wjd.v4.i4.151. |
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|
| Reduction in FPG (overall and subpopulations) |
| 24 weeks |
| Responder rates (overall and subpopulations) | 24 weeks |
| Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations) | 24 weeks |
| Heidelberg Heights |
| Australia |
| Novartis Investigative Site | Parkville | Australia |
| Novartis Investigative Site #1 | Wollongong | Australia |
| Novartis Investigative Site #2 | Wollongong | Australia |
| Novartis Investigative Site | Bonheiden | Belgium |
| Novartis Investigative Site | Edegem | Belgium |
| Novartis Investigative Site | Genk | Belgium |
| Novartis Investigative Site | La Louvière | Belgium |
| Novartis Investigative Site | Ronse | Belgium |
| Novartis Investigative Site #1 | Ostrava | Czechia |
| Novartis Investigative Site #2 | Ostrava | Czechia |
| Novartis Investigative Site #3 | Ostrava | Czechia |
| Novartis Investigative Site | Aßlar | Germany |
| Novartis Investigative Site | Bensheim | Germany |
| Novartis Investigative Site | Berlin | Germany |
| Novartis Investigative Site | Einbeck | Germany |
| Novartis Investigative Site #1 | Hamburg | Germany |
| Novartis Investigative Site #2 | Hamburg | Germany |
| Novartis Investigative Site #3 | Hamburg | Germany |
| Novartis Investigative Site #4 | Hamburg | Germany |
| Novartis Investigative Site | Hanover | Germany |
| Novartis Investigative Site #1 | Kassel | Germany |
| Novartis Investigative Site #2 | Kassel | Germany |
| Novartis Investigative Site | München | Germany |
| Novartis Investigative Site | Saarlouis | Germany |
| Novartis Investigative Site | Schliemannstadt Neubukow | Germany |
| Novartis Investigative Site | Tübingen | Germany |
| Novartis Investigative Site #1 | Guatemala City | Guatemala |
| Novartis Investigative Site #2 | Guatemala City | Guatemala |
| Novartis Investigative Site #3 | Guatemala City | Guatemala |
| Novartis Investigative Site #4 | Guatemala City | Guatemala |
| Novartis Investigative Site #5 | Guatemala City | Guatemala |
| Novartis Investigative Site #1 | Hong Kong | Hong Kong |
| Novartis Investigative Site #2 | Hong Kong | Hong Kong |
| Novartis Investigative Site #1 | Budapest | Hungary |
| Novartis Investigative Site #2 | Budapest | Hungary |
| Novartis Investigative Site | Dunaújváros | Hungary |
| Novartis Investigative Site | Nyíregyháza | Hungary |
| Novartis Investigative Site | Szeged | Hungary |
| Novartis Investigative Site | Indore | India |
| Novartis Investigative Site | Jaipur | India |
| Novartis Investigative Site | Karnāl | India |
| Novartis Investigative Site #2 | Mumbai | India |
| Novartis Investigative Site #1 | Mumbia | India |
| Novartis Investigative Site #1 | Nagpur | India |
| Novartis Investigative Site #2 | Nagpur | India |
| Novartis Investigative Site | Nashik | India |
| Novartis Investigative Site #1 | Trivandrum | India |
| Novartis Investigative Site #2 | Trivandrum | India |
| 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 | Banská Bystrica | Slovakia |
| Novartis Investigative Site #1 | Bratislava | Slovakia |
| Novartis Investigative Site #2 | Bratislava | Slovakia |
| Novartis Investigative Site #3 | Bratislava | Slovakia |
| Novartis Investigative Site #1 | Košice | Slovakia |
| Novartis Investigative Site #2 | Košice | Slovakia |
| Novartis Investigative Site | Prešov | Slovakia |
| Novartis Investigative Site | Štúrovo | Slovakia |
| Novartis Investigative Site | Carmarthen | United Kingdom |
| Novartis Investigative Site #1 | Glasgow | United Kingdom |
| Novartis Investigative Site #2 | Glasgow | United Kingdom |
| 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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