Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
NCT ID: NCT00660907
Last Updated: 2015-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1217 participants
INTERVENTIONAL
2008-03-31
2013-01-31
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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1
dapagliflozin plus metformin
dapagliflozin
Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
metformin hydrochloride
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
2
glipizide plus metformin
glipizide
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
metformin hydrochloride
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Interventions
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dapagliflozin
Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
glipizide
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
metformin hydrochloride
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
* HbA1c \>6.5% and \</=10%
Exclusion Criteria
* Insulin therapy within one year of enrolment
* Renal (kidney) failure or dysfunction
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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Michael A. Nauck, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Diabeteszentrum Bad Lauterberg, Germany
Locations
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Research Site
Buenos Aires, , Argentina
Research Site
Caba, , Argentina
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Capital Federal, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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La Plata, , Argentina
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Rosario, , Argentina
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Santa Fe, , Argentina
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L'Aigle, , France
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Mûrs-Erigné, , France
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Nantes, , France
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Paris, , France
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Tours, , France
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Vannes, , France
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Bad Lauterberg im Harz, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Heilbronn, , Germany
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Ludwigshafen, , Germany
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Mainz, , Germany
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Pirna, , Germany
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Schmiedeberg, , Germany
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Wangen, , Germany
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Perugia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Acapulco, , Mexico
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Guadalajara, , Mexico
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México, , Mexico
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Veracruz, , Mexico
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Deurne, , Netherlands
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Gorinchem, , Netherlands
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Groningen, , Netherlands
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Lichtenvoorde (gld), , Netherlands
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Losser, , Netherlands
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Poortvliet, , Netherlands
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Rotterdam, , Netherlands
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The Hague, , Netherlands
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Wildervank, , Netherlands
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Zutphen, , Netherlands
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Cape Town, , South Africa
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Durban, , South Africa
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eMkhomazi, , South Africa
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Johannesburg, , South Africa
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Parow, , South Africa
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Pretoria, , South Africa
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Witbank, , South Africa
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Alicante, , Spain
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Alzira (Valencia), , Spain
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Barcelona, , Spain
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Cornellá de Llobregat (bcn), , Spain
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Madrid, , Spain
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Seville, , Spain
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Gothenburg, , Sweden
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Järfälla, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Skene, , Sweden
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Södertälje, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Addlestone, , United Kingdom
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Aylesbury, , United Kingdom
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Bath, , United Kingdom
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Bolton, , United Kingdom
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Bury Saint Edmonds, , United Kingdom
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Cookstown, , United Kingdom
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Coventry, , United Kingdom
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Ecclesfield, , United Kingdom
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Edinburgh, , United Kingdom
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Mortimer Reading, , United Kingdom
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Trowbridge, , United Kingdom
Countries
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References
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Nauck MA, Del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep;34(9):2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4.
Nauck M, del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. [Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S6-15. doi: 10.1055/s-0032-1305283. Epub 2013 Mar 25. German.
Related Links
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Other Identifiers
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D1690C00004
Identifier Type: -
Identifier Source: org_study_id
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