A Phase 4 interventional study of Empagliflozin 10 MG and Dapagliflozin 10 MG in Diabetes Mellitus, Type 2, Heart Failure and Chronic Kidney Diseases, sponsored by Herlev and Gentofte Hospital. Recruiting at 12 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Herlev and Gentofte Hospital · Phase 4, Interventional, and Treatment
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
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 17,200 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Herlev and Gentofte Hospital is the lead sponsor of 75 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Head-to-head comparator
Drug: Empagliflozin 10 MG
Head-to-head comparator
Drug: Dapagliflozin 10 MG
Once daily
Once daily
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
Hospitalization for ketoacidosis
Safety outcome
Time frame: Up to 24 months
Hospitalization for limb amputation
Safety outcome
Time frame: Up to 24 months
Hospitalization for genitourinary infection
Safety outcome
Time frame: Up to 24 months
Hospitalization for fracture
Safety outcome
Time frame: Up to 24 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Empagliflozin · Dapagliflozin
Herlev and Gentofte Hospital