This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
922
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Research Site
Gulf Shores, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Burbank, California, United States
Research Site
Garden Grove, California, United States
Research Site
Huntington Park, California, United States
Research Site
Adjusted Mean Change in HbA1c Levels
To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.
Time frame: Baseline to Week 24
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.
Time frame: Baseline to week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)
To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.
Time frame: Baseline to Week 8
Adjusted Mean Percent Change in Body Weight
To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Time frame: Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)
To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Time frame: Baseline to Week 24
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.
Time frame: Baseline to Week 24
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Lancaster, California, United States
Research Site
Salinas, California, United States
Research Site
San Marino, California, United States
Research Site
San Ramon, California, United States
Research Site
Tustin, California, United States
...and 130 more locations