Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
NCT ID: NCT00831779
Last Updated: 2017-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2009-04-30
2010-08-31
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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Dapagliflozin
Dapagliflozin
Tablets, Oral, 5 mg, once daily, 12 weeks
Placebo
Placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks
Interventions
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Dapagliflozin
Tablets, Oral, 5 mg, once daily, 12 weeks
Placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment
* C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
* BMI ≤ 45.0 kg/m2
Exclusion Criteria
* Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 3X ULN
* Serum Total Bilirubin \> 2 mg/dL (34.2 μmol/l)
* 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, oncological, endocrine, psychiatric, or rheumatic diseases
35 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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Va San Diego Healthcare System
San Diego, California, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Temple University General Clinical Research Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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MB102-045
Identifier Type: -
Identifier Source: org_study_id
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