The aim of this clinical trial is investigate the comparative effectiveness of empagliflozin and dapagliflozin for the treatment of diabetes, chronic kidney disease, and heart failure. Patients who are prescribed either empagliflozin or dapagliflozin, as part of daily clinical practice at the participating sites, will be included in the study. Treatment will be randomized automatically through the electronic health record software in clusters defined by time of day. https://www.appletreestudy.com
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17,200
Once daily
Once daily
Bispebjerg Hospital
Copenhagen, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGHerlev and Gentofte Hospital
Herlev, Denmark
RECRUITINGSteno Diabetes Center Copenhagen
Herlev, Denmark
RECRUITINGNordsjællands Hospital
Hillerød, Denmark
RECRUITINGHolbæk Sygehus
Holbæk, Denmark
RECRUITINGHvidovre Hospital
Hvidovre, Denmark
RECRUITINGSjællands Universitetshospital
Køge, Denmark
RECRUITINGNykøbing F. Sygehus
Nykøbing Falster, Denmark
RECRUITINGSjællands Universitetshospital
Roskilde, Denmark
RECRUITING...and 2 more locations
Time to the first occurrence of any of the components of the composite: all-cause mortality, hospitalization for heart failure, hospitalization for myocardial infarction, hospitalization for ischemic stroke, and incident or worsening nephropathy.
Incident or worsening nephropathy is defined as: * A sustained decrease in estimated glomerular filtration rate (eGFR) of ≥40% from baseline * A sustained decrease in eGFR of ≤10 per minute per 1.73 m2 * Initiation of dialysis * Kidney transplantation
Time frame: Up to 24 months
All-cause mortality
Time frame: Up to 24 months
Hospitalization for heart failure
Time frame: Up to 24 months
Hospitalization for myocardial infarction
Time frame: Up to 24 months
Hospitalization for ischemic stroke
Time frame: Up to 24 months
Incident or worsening nephropathy
Defined as a sustained decrease in estimated glomerular filtration rate (eGFR) of ≥40% from baseline, a sustained decrease in eGFR of ≤10 per minute per 1.73 m2, initiation of dialysis, or kidney transplantation
Time frame: Up to 24 months
Hospitalization for coronary revascularization
Time frame: Up to 24 months
Hospitalization for unstable angina
Time frame: Up to 24 months
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