Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
NCT ID: NCT01392677
Last Updated: 2014-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
311 participants
INTERVENTIONAL
2011-10-31
2013-08-31
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
QUADRUPLE
Study Groups
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Dapagliflozin 10 mg tablet
dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
matching placebo tablet
placebo
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
Interventions
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dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
placebo
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
Eligibility Criteria
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Inclusion Criteria
* Men or women age ≥ 18 years old
* Stable dose combination of metformin and sulfonylurea
* HbA1c ≥7.7% and ≤11.0%
Exclusion Criteria
* Recent cardiovascular events
* Kidney or urological disorders
* Hepatic disorders
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Eva Johnsson, PhD, Medical Science Director
Role: STUDY_DIRECTOR
AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
Stephan Matthaei, Prof.Dr.med
Role: PRINCIPAL_INVESTIGATOR
Diabetes-Zentrum Quakenbruck
Locations
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Research Site
Edmonton, Alberta, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Sydney Mines, Nova Scotia, Canada
Research Site
Brampton, Ontario, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Markham, Ontario, Canada
Research Site
Smiths Falls, Ontario, Canada
Research Site
Kensington, Prince Edward Island, Canada
Research Site
Laval, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Beroun, , Czechia
Research Site
České Budějovice, , Czechia
Research Site
Jílové u Prahy, , Czechia
Research Site
Prague, , Czechia
Research Site
Semily, , Czechia
Research Site
Vyškov, , Czechia
Research Site
Aßlar, , Germany
Research Site
Berlin, , Germany
Research Site
Dresden, , Germany
Research Site
Falkensee, , Germany
Research Site
Neuwied, , Germany
Research Site
Pirna, , Germany
Research Site
Kielce, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Warsaw, , Poland
Research Site
Zgierz, , Poland
Research Site
Banská Bystrica, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Považská Bystrica, , Slovakia
Research Site
Rimavská Sobota, , Slovakia
Research Site
Barcelona, Catalonia, Spain
Research Site
Santa Coloma de Gramanet (bcn), Catalu?a, Spain
Research Site
A Coruña, Galicia, Spain
Research Site
Oviedo, Principality of Asturias, Spain
Research Site
A Coruña, , Spain
Research Site
Barcelona, , Spain
Research Site
Oviedo, , Spain
Research Site
Santa Coloma de Gramenet (bcn), , Spain
Countries
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References
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Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15.
Related Links
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Other Identifiers
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D1693C00005
Identifier Type: -
Identifier Source: org_study_id
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