Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
NCT ID: NCT01031680
Last Updated: 2013-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
922 participants
INTERVENTIONAL
2010-02-28
2012-12-31
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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1
Dapagliflozin 10 mg tablet
Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
2
Matching placebo tablet
Placebo
Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Interventions
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Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
Placebo
Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Eligibility Criteria
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Inclusion Criteria
* Cardiovascular disease
* Hypertension
Exclusion Criteria
* Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
* Any clinically significant illness, which would compromise the patient's safety and their participation in the study
45 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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Dr. William Cefalu
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Research Site
Gulf Shores, Alabama, United States
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Phoenix, Arizona, United States
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Burbank, California, United States
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Garden Grove, California, United States
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Huntington Park, California, United States
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Lancaster, California, United States
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Salinas, California, United States
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San Marino, California, United States
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San Ramon, California, United States
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Tustin, California, United States
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Colorado Springs, Colorado, United States
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Waterbury, Connecticut, United States
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Clearwater, Florida, United States
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Deerfield Beach, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Port Charlotte, Florida, United States
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Port Orange, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Columbus, Georgia, United States
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Decatur, Georgia, United States
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Stone Mountain, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Wichita, Kansas, United States
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Baton Rouge, Louisiana, United States
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Lake Charles, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Brick, New Jersey, United States
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Oradell, New Jersey, United States
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New Hyde Park, New York, United States
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The Bronx, New York, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Charleston, South Carolina, United States
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Kingsport, Tennessee, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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North Richland Hills, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Ogden, Utah, United States
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Danville, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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La Plata, 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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Mendoza, Mendoza Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Calgary, Alberta, Canada
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New Westminster, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Carbonear, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Courtice, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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Ottawa, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Toronto, Ontario, Canada
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Lachine, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Marc-des-Carrieres, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Potsdam, BR, Germany
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Bad Nauheim, , Germany
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Berlin, , Germany
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Erdmannhausen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Heilbronn, , Germany
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Hildesheim, , Germany
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Mainz, , Germany
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Münster, , Germany
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Potsdam, , Germany
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Speyer, , Germany
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Wahlstedt, , Germany
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Brasov, Brașov County, Romania
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Suceava, Suceava, Romania
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Brăila, , Romania
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Bucharest, , Romania
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Constanța, , Romania
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Iași, , Romania
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Sibiu, , Romania
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Dolný Kubín, , Slovakia
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Komárno, , Slovakia
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Košice, , Slovakia
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Kysucké Nové Mesto, , Slovakia
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Liptovský Hrádok, , Slovakia
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Lučenec, , Slovakia
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Nitra, , Slovakia
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Považská Bystrica, , Slovakia
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Prievidza, , Slovakia
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Rimavská Sobota, , Slovakia
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Ružomberok, , Slovakia
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Žilina, , Slovakia
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Córdoba, Andalusia, Spain
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Granada, Andalusia, Spain
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Seville, Andalusia, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Barcelona, Catalonia, Spain
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Lleida, Catalonia, Spain
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Olot (girona), Catalonia, Spain
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A Coruña, Galicia, Spain
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Santiago de Compostela, Galicia, Spain
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Majadahonda, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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San Juan (alicante), Valencia, Spain
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Valencia, Valencia, Spain
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Tainan County, Taiwan, Taiwan
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Hanoi, Vietnam, Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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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.
Cefalu WT, Leiter LA, de Bruin TW, Gause-Nilsson I, Sugg J, Parikh SJ. Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension. Diabetes Care. 2015 Jul;38(7):1218-27. doi: 10.2337/dc14-0315. Epub 2015 Apr 7.
Other Identifiers
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D1690C00018
Identifier Type: -
Identifier Source: org_study_id