Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
833 participants
INTERVENTIONAL
2009-10-31
2011-09-30
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
QUADRUPLE
Study Groups
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1
Dapagliflozin 10 mg tablet
Dapagliflozin
10 mg tablet, oral, once daily, 48 weeks
2
Matching placebo tablet
Placebo
Matching placebo tablet
Interventions
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Dapagliflozin
10 mg tablet, oral, once daily, 48 weeks
Placebo
Matching placebo tablet
Eligibility Criteria
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Inclusion Criteria
* Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
* Patients will be screened by a blood test and only those who need additional therapy can be enrolled
Exclusion Criteria
* Patients with very poorly controlled diabetes
* Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
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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Serge Jabbour, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University, Philadelphia
Locations
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Research Site
Huntsville, Alabama, United States
Research Site
Ozark, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
Research Site
Greenbrae, California, United States
Research Site
Laguna Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Riverside, California, United States
Research Site
West Hills, California, United States
Research Site
Boca Raton, Florida, United States
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DeLand, Florida, United States
Research Site
Jacksonville, Florida, United States
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Longwood, Florida, United States
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Miami, Florida, United States
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Port Orange, Florida, United States
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West Palm Beach, Florida, United States
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Stone Mountain, Georgia, United States
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Wichita, Kansas, United States
Research Site
Lake Charles, Louisiana, United States
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Edina, Minnesota, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Staten Island, New York, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medord, Oregon, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Mt. Pleasant, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Simpsonville, South Carolina, United States
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Bristol, Tennessee, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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North Richland Hills, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Burke, Virginia, United States
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Manassas, Virginia, United States
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Richmond, Virginia, United States
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Lakewood, Washington, United States
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Berazategui, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Lanús, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Morón, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Caba, Buenos Aires F.D., Argentina
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Córdoba, Córdoba Province, Argentina
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Salta, Salta Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Bad Nauheim, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Meissen, , Germany
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Münster, , Germany
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Pirna, , Germany
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Wangen, , Germany
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Guadalajara, Jalisco, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Ciechocinek, , Poland
Research Site
Czechowice-Dziedzice, , Poland
Research Site
Gdansk, , Poland
Research Site
Gniewkowo, , Poland
Research Site
Krakow, , Poland
Research Site
Krotoszyn, , Poland
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Mrągowo, , Poland
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Poznan, , Poland
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Sopot, , Poland
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Torun, , Poland
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Zabrze, , Poland
Research Site
Łęczyca, , Poland
Research Site
Bolton, Lancs, United Kingdom
Research Site
Burbage, Leicester, United Kingdom
Research Site
Sunbury-on-Thames, Middlesex, United Kingdom
Research Site
Wansford, Peterborough, United Kingdom
Research Site
Ecclesfield, Sheffield, United Kingdom
Research Site
Addlestone, Surrey, United Kingdom
Research Site
Bath, , United Kingdom
Research Site
Belfast, , United Kingdom
Research Site
Blackpool, , United Kingdom
Research Site
Coventry, , United Kingdom
Research Site
Harrow, , United Kingdom
Countries
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References
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Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-50. doi: 10.2337/dc13-0467. Epub 2013 Oct 21.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Related Links
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D1690C00010\_Clinical\_Study\_Report\_Synopsis
D1690C00010\_Revised\_CSP1\_and\_Amdt\_1\_Priv\_Redacted
Other Identifiers
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D1690C00010
Identifier Type: -
Identifier Source: org_study_id
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