Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
NCT ID: NCT00976495
Last Updated: 2017-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2009-10-31
2010-11-30
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
BASIC_SCIENCE
DOUBLE
Study Groups
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Dapagliflozin
Dapagliflozin
Tablets, Oral, 10 mg, once daily, 12 weeks
Placebo
Tablets, Oral, 0 mg, once daily, 12 weeks
Hydrochlorothiazide
Hydrochlorothiazide
Tablets, Oral, 25 mg, once daily, 12 weeks
Interventions
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Dapagliflozin
Tablets, Oral, 10 mg, once daily, 12 weeks
Placebo
Tablets, Oral, 0 mg, once daily, 12 weeks
Hydrochlorothiazide
Tablets, Oral, 25 mg, once daily, 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit
* Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and \< 165 mmHg, AND/OR diastolic BP (DBP) ≥ 80 and \< 105 mmHg
* C-peptide ≥ 0.8 ng/mL
* Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula \> 60 mL/min/1.73m² and \< 150 mL/min/1.73m²
* Urine albumin:creatinine ratio (UACR) \< 300 mg/g
* BMI ≤ 45.0 kg/m2
Exclusion Criteria
* History of adverse reaction to radio-contrast dye
* Allergy or contraindication to use of thiazide diuretics
* Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 3X ULN
* Serum Total Bilirubin \> 1.5X ULN
* Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases
18 Years
70 Years
ALL
No
Sponsors
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Astra Zeneca, Bristol-Myers Squibb
OTHER
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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Advanced Clinical Res Inst
Anaheim, California, United States
Torrance Clinical Research
Lomita, California, United States
Elite Research Institute
Miami, Florida, United States
Compass Research, Llc
Orlando, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
University Of Michigan
Ann Arbor, Michigan, United States
Prism Research
Saint Paul, Minnesota, United States
Memorial Hospital Of Rhode Island
Pawtucket, Rhode Island, United States
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, United States
Local Institution
Toronto, Ontario, Canada
Local Institution
Laval, Quebec, Canada
Local Institution
Groningen, , Netherlands
Countries
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Related Links
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MB102035\_Redacted\_CSR\_synopsis
Other Identifiers
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EUDRACT #: 2009-010221-39
Identifier Type: -
Identifier Source: secondary_id
MB102-035
Identifier Type: -
Identifier Source: org_study_id
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