Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
NCT ID: NCT01233622
Last Updated: 2017-02-23
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
317 participants
INTERVENTIONAL
2010-10-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vildagliptin (metformin + glimepiride)
Vildagliptin
Placebo (metformin + glimepiride)
Placebo
Interventions
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Vildagliptin
Placebo
Eligibility Criteria
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Inclusion Criteria
* Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
* Age: ≥18 to ≤ 80 years
* HbA1c of ≥ 7.5 and ≤ 11.0%
* Body Mass Index (BMI) ≥22 to ≤45 kg/m2
Exclusion Criteria
* Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
* Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
18 Years
80 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Box Hill, , Australia
Novartis Investigative Site
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
Padua, , 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
Countries
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References
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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.
Other Identifiers
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EudraCT 2010-021097-11
Identifier Type: -
Identifier Source: secondary_id
CLAF237A23152
Identifier Type: -
Identifier Source: org_study_id
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