The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
Tablets, Oral, 5 mg, once daily, 12 weeks
Tablets, Oral, 0 mg, Once daily, 12 weeks
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
Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.
Time frame: From Baseline to Week 12
Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.
Time frame: From Baseline to Week 12
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