A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
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
Conditions studied
Diabetes Mellitus, Type 2, Heart Failure, Chronic Kidney Diseases
About this study
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
Interventions
- Drug: Empagliflozin 10 MG — Once daily
- Drug: Dapagliflozin 10 MG — Once daily
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. (Up to 24 months)
Eligibility information
Study locations
- Bispebjerg Hospital, Copenhagen, Denmark
- Rigshospitalet, Copenhagen, Denmark
- Herlev and Gentofte Hospital, Herlev, Denmark
- Steno Diabetes Center Copenhagen, Herlev, Denmark
- Nordsjællands Hospital, Hillerød, Denmark
- Holbæk Sygehus, Holbæk, Denmark
- Hvidovre Hospital, Hvidovre, Denmark
- Sjællands Universitetshospital, Køge, Denmark
- Nykøbing F. Sygehus, Nykøbing Falster, Denmark
- Sjællands Universitetshospital, Roskilde, Denmark
Showing 10 of 12 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.