A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin 10 MG, Dapagliflozin 10 MG.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Heart Failure, Chronic Kidney Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 outcome measures
- 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. [Time frame: Up to 24 months]
Secondary outcome measures (7)
- 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 [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]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years or more
Exclusion criteria
- Incapabability of giving informed consent
- Withdrawal of informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 12 centers
- Bispebjerg Hospital — Copenhagen
- Rigshospitalet — Copenhagen
- Herlev and Gentofte Hospital — Herlev
- Steno Diabetes Center Copenhagen — Herlev
- Nordsjællands Hospital — Hillerød
- Holbæk Sygehus — Holbæk
- Hvidovre Hospital — Hvidovre
- Sjællands Universitetshospital — Køge
- … and 4 more centers
Identifiers
NCT: NCT06642272 · 2401312