This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17,190
Oral dose (od)
Oral dose (od)
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke
Safety and co-primary efficacy
Time frame: up to 5.2 years
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Co-primary efficacy
Time frame: up to 5.2 years
Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.
Secondary
Time frame: up to 5.2 years
Subjects Included in the Endpoint of All-cause Mortality.
Secondary
Time frame: up to 5.2 years
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Research Site
Alexander City, Alabama, United States
Research Site
Athens, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Montgomery, Alabama, United States
Research Site
Mesa, Arizona, United States
Research Site
Mesa, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Alhambra, California, United States
...and 795 more locations