Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
NCT ID: NCT00736879
Last Updated: 2017-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
497 participants
INTERVENTIONAL
2008-09-22
2009-12-29
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 1 mg
Dapagliflozin: 1 mg
Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Dapagliflozin 5 mg
Dapagliflozin: 5 mg
Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Placebo
Placebo: 0 mg
Placebo
Tablets, Oral, Once Daily, Up to 24 weeks
Interventions
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Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Placebo
Tablets, Oral, Once Daily, Up to 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
* C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
* Body Mass Index ≤ 45 kg/m²
* Must be able to perform self monitoring of blood glucose
Exclusion Criteria
* Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
* Creatinine kinase \>3\* ULN
* Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
18 Years
77 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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Dedicated Clinical Research
Litchfield Park, Arizona, United States
43rd Medical Associates, P.C.
Phoenix, Arizona, United States
Clinical Research Advantage, Inc.
Tempe, Arizona, United States
Valley Research
Fresno, California, United States
Marina Raikhel, Md, Faafp
Lomita, California, United States
Richard S. Cherlin, Md
Los Gatos, California, United States
Orange County Research Center
Tustin, California, United States
Family Physicians Of Greeley
Greeley, Colorado, United States
Coastal Connecticut Research, Llc
New London, Connecticut, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, United States
Westside Center For Clinical Research
Jacksonville, Florida, United States
Panhandle Family Care Associates
Marianna, Florida, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Belzoni Clinical Research
Belzoni, Mississippi, United States
R-Research
Hamilton, New Jersey, United States
Internist Associates Of Central New York
Syracuse, New York, United States
Southgate Medical Group
West Seneca, New York, United States
Down East Medical Associates, Pa
Morehead City, North Carolina, United States
James J. Brown, Md
Akron, Ohio, United States
Integris Family Care South
Oklahoma City, Oklahoma, United States
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States
Abbott Clinical Research Group, Inc
San Antonio, Texas, United States
Avastra Clinical Trials
Midvale, Utah, United States
Optimum Clinical Research, Inc.
Salt Lake City, Utah, United States
Capital Clinical Research Center
Olympia, Washington, United States
Stephen G. Danley, Do
Spokane, Washington, United States
Local Institution
Calgary, Alberta, Canada
Local Institution
Coquitlam, British Columbia, Canada
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Bathurst, New Brunswick, Canada
Local Institution
Ajax, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Waterloo, Ontario, Canada
Local Institution
Drummondville, Quebec, Canada
Local Institution
L'Ancienne-Lorette, Quebec, Canada
Local Institution
Saint-Léonard, Quebec, Canada
Local Institution
Ahmedabad, , India
Local Institution
Bangalore, , India
Local Institution
Bangalore, , India
Local Institution
Jaipur, , India
Local Institution
Jaipur, , India
Local Institution
Durango, Durango, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Df, Mexico City, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Veracruz, Veracruz, Mexico
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Ponce, , Puerto Rico
Local Institution
Ponce, , Puerto Rico
Local Institution
Kursk, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saratov, , Russia
Local Institution
Smolensk, , Russia
Local Institution
Benoni, Gauteng, South Africa
Local Institution
Soweto, Gauteng, South Africa
Local Institution
Paarl, Western Cape, South Africa
Local Institution
Tygerberg, Western Cape, South Africa
Countries
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References
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Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
Related Links
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Investigator Inquiry form
Other Identifiers
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MB102-032
Identifier Type: -
Identifier Source: org_study_id
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