About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or more
Disqualifiers
Incapabability of giving informed consent
Withdrawal of informed consent
Trial design
Parallel
Treatments tested in this trial
Empagliflozin 10 MG
DrugOnce daily
Dapagliflozin 10 MG
DrugOnce daily
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
All-cause mortality
Hospitalization for heart failure
Hospitalization for myocardial infarction
Hospitalization for ischemic stroke
Other outcomes
Hospitalization for ketoacidosis
Safety outcome
Hospitalization for limb amputation
Safety outcome
Hospitalization for genitourinary infection
Safety outcome
Hospitalization for fracture
Safety outcome
Sponsors and contacts
Click on the lead sponsor to view all of their trials.