Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
NCT ID: NCT00663260
Last Updated: 2017-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
631 participants
INTERVENTIONAL
2008-06-30
2011-06-30
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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Dapagliflozin (10 mg)
Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Dapagliflozin (5 mg)
Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Placebo
Placebo
Tablets, Oral, 0 mg, Once Daily, 104 weeks
Interventions
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Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Placebo
Tablets, Oral, 0 mg, Once Daily, 104 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of moderate renal impairment
Exclusion Criteria
* Serum total bilirubin \> 1.5 times ULN
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
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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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Vista Medical Research, Inc.
Mesa, Arizona, United States
Valley Research
Fresno, California, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
Office Of Richard Cherlin, Md
Los Gatos, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
Apex Research Of Riverside
Riverside, California, United States
La Biomed At Harbor Ucla Med Ctr.
Torrance, California, United States
Endocrine Associates Of The Rockies
Denver, Colorado, United States
Panhandle Family Care Associates
Marianna, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States
Kcva Medical Center Research Svc (151)
Kansas City, Missouri, United States
Va Nebraska-Western Iowa Health Care System (Nwihcs)
Omaha, Nebraska, United States
University Of Medicine And Dentistry Of New Jersey
Voorhees Township, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
Slocum-Dickson Medical Group, Pllc
New Hartford, New York, United States
Community Health Care Of Manchester
Akron, Ohio, United States
Center For Thyroid Diseases And Endocrinology
Beachwood, Ohio, United States
Physician Research, Inc.
Zanesville, Ohio, United States
Univ Of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Rogue Valley Clinical Research
Medford, Oregon, United States
Drexel University College Of Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Low Country Internal Medicine Of Sc, Pa
Charleston, South Carolina, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Research Institute Of Dallas
Dallas, Texas, United States
Westbury Medical Clinic P.A.
Houston, Texas, United States
The Strelitz Diabetes Center
Norfolk, Virginia, United States
Capital Clinical Research Center
Olympia, Washington, United States
Cedar Research Llc
Tacoma, Washington, United States
Aurora Advanced Healthcare
Milwaukee, Wisconsin, United States
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Zárate, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Salta, Salta Province, Argentina
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Camperdown, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Woollongong, New South Wales, Australia
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Launceston, Tasmania, Australia
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Calgary, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Barrie, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Laval, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Regina, Saskatchewan, Canada
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Copenhagen Nv, , Denmark
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Gentofte Municipality, , Denmark
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Hvidovre, , Denmark
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Besançon, , France
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Brest, , France
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Paris, , France
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Paris, , France
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Poitiers, , France
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Indore, Madhya Pradesh, India
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Pune, Maharashtra, India
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Bangalore, , India
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Bangalore, , India
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Chennai, , India
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Pune, Maharashtra, , India
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Rajasthan, , India
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Chieri, , Italy
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Chieti Scalo, , Italy
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Modena, , Italy
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Padua, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Siena, , Italy
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Durango, Durango, Mexico
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Celaya, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Df, Mexico City, Mexico
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Df, Mexico City, Mexico
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Df, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Arequipa, Arequipa, Peru
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Lima Cercado, Lima region, Peru
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Caguas, , Puerto Rico
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San Juan, , Puerto Rico
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Singapore, , Singapore
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Barcelona, , Spain
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San Sebastian de Los, , Spain
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Vizcaya, , Spain
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.
Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjostrom CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15. No abstract available.
Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.
Related Links
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Publication long-term
MB102029\_Redacted\_CSR\_synopsis
Other Identifiers
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MB102-029
Identifier Type: -
Identifier Source: org_study_id
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