Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
NCT ID: NCT01257451
Last Updated: 2012-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
431 participants
INTERVENTIONAL
2010-12-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vildagliptin
Vildagliptin
vildagliptin 50mg bid
Placebo
Placebo
Placebo 50mg bid
Interventions
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Vildagliptin
vildagliptin 50mg bid
Placebo
Placebo 50mg bid
Eligibility Criteria
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Inclusion Criteria
* patients with a confirmed diagnosis of T2DM
* HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
* body mass index (BMI) in the range of 19-45kg/m2
Exclusion Criteria
* previous or current participation in any vildagliptin clinical study.
* history of hypersensitivity to DPP-4 inhibitors.
* concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
70 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals Corporation
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Wichelen, Belgium, Belgium
Novartis Investigative Site
Buizingen, , Belgium
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De Pinte, , Belgium
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Genk, , Belgium
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Mouscron, , Belgium
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Nazareth, , Belgium
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Oostham, , Belgium
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Blagoevgrad, Bulgaria, Bulgaria
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Dimitrovgrad, Bulgaria, Bulgaria
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Plovdiv, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Varna, Bulgaria, Bulgaria
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Lahti, Suomi, Finland
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Helsinki, , Finland
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Oulu, , Finland
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Münster, Germany, Germany
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Völlkingen, Germany, Germany
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Bamberg, , Germany
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Beckum, , Germany
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Berlin, , Germany
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Eisleben Lutherstadt, , Germany
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Falkensee, , Germany
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Lichtenfels, , Germany
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Magdeburg, , Germany
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Mammendorf, , Germany
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Potsdam, , Germany
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Sulzbach-Rosenberg, , Germany
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Wetter, , Germany
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Bratislava, Slovak Republic, Slovakia
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Ľubochňa, Slovak Republic, Slovakia
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Levice, Slovakia, Slovakia
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Nové Zámky, Slovakia, Slovakia
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Pie¿¿any, Slovakia, Slovakia
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Košice, , Slovakia
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Ružomberok, , Slovakia
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Alicante, Alicante, Spain
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Sanlúcar de Barrameda, Andalusia, Spain
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Centelles, Barcelona, Spain
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Alzira, Valencia, Spain
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Truro, Cornwall, United Kingdom
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Birmingham, , United Kingdom
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Exeter, , United Kingdom
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Stevenage, , United Kingdom
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Wiltshire, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2010-022658-18
Identifier Type: -
Identifier Source: secondary_id
CLAF237A23150
Identifier Type: -
Identifier Source: org_study_id