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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022658-18 |
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This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | vildagliptin 50mg bid |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram. | 24 weeks | |
| To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Pharmaceuticals Corporation | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Wichelen | Belgium | 9260 | Belgium | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23706759 | Derived | Strain WD, Lukashevich V, Kothny W, Hoellinger MJ, Paldanius PM. Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study. Lancet. 2013 Aug 3;382(9890):409-416. doi: 10.1016/S0140-6736(13)60995-2. Epub 2013 May 23. |
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| Drug |
Placebo 50mg bid |
|
| 24 weeks |
| To assess the responder rates of patients treated with vildagliptin as compared to placebo | 24 weeks |
| Buizingen |
| 1501 |
| Belgium |
| Novartis Investigative Site | De Pinte | 9840 | Belgium |
| Novartis Investigative Site | Genk | 3600 | Belgium |
| Novartis Investigative Site | Mouscron | 7700 | Belgium |
| Novartis Investigative Site | Nazareth | 9810 | Belgium |
| Novartis Investigative Site | Oostham | 3945 | Belgium |
| Novartis Investigative Site | Blagoevgrad | Bulgaria | 2700 | Bulgaria |
| Novartis Investigative Site | Dimitrovgrad | Bulgaria | 6400 | Bulgaria |
| Novartis Investigative Site | Plovdiv | Bulgaria | 4001 | Bulgaria |
| Novartis Investigative Site | Sofia | Bulgaria | 1431 | Bulgaria |
| Novartis Investigative Site | Varna | Bulgaria | 9002 | Bulgaria |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Lahti | Suomi | 15110 | Finland |
| Novartis Investigative Site | Helsinki | 00180 | Finland |
| Novartis Investigative Site | Oulu | FIN-90100 | Finland |
| Novartis Investigative Site | Münster | Germany | 48143 | Germany |
| Novartis Investigative Site | Völlkingen | Germany | 66333 | Germany |
| Novartis Investigative Site | Bamberg | 96050 | Germany |
| Novartis Investigative Site | Beckum | 59269 | Germany |
| Novartis Investigative Site | Berlin | 10115 | Germany |
| Novartis Investigative Site | Eisleben Lutherstadt | 06295 | Germany |
| Novartis Investigative Site | Falkensee | 14612 | Germany |
| Novartis Investigative Site | Lichtenfels | 96215 | Germany |
| Novartis Investigative Site | Magdeburg | 39112 | Germany |
| Novartis Investigative Site | Mammendorf | 82291 | Germany |
| Novartis Investigative Site | Potsdam | 14469 | Germany |
| Novartis Investigative Site | Sulzbach-Rosenberg | 92237 | Germany |
| Novartis Investigative Site | Wetter | 58300 | Germany |
| Novartis Investigative Site | Bratislava | Slovak Republic | 811 02 | Slovakia |
| Novartis Investigative Site | Ľubochňa | Slovak Republic | 03491 | Slovakia |
| Novartis Investigative Site | Levice | Slovakia | 934 01 | Slovakia |
| Novartis Investigative Site | Nové Zámky | Slovakia | 940 01 | Slovakia |
| Novartis Investigative Site | Pie¿¿any | Slovakia | 92101 | Slovakia |
| Novartis Investigative Site | Košice | 040 22 | Slovakia |
| Novartis Investigative Site | Ružomberok | 034 01 | Slovakia |
| Novartis Investigative Site | Alicante | Alicante | 03114 | Spain |
| Novartis Investigative Site | Sanlúcar de Barrameda | Andalusia | 11540 | Spain |
| Novartis Investigative Site | Centelles | Barcelona | 08540 | Spain |
| Novartis Investigative Site | Alzira | Valencia | 46600 | Spain |
| Novartis Investigative Site | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Novartis Investigative Site | Birmingham | B9 5SS | United Kingdom |
| Novartis Investigative Site | Exeter | EX2 5DW | United Kingdom |
| Novartis Investigative Site | Stevenage | SG1 4AB | United Kingdom |
| Novartis Investigative Site | Wiltshire | SN15 2SB | 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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