A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev and Gentofte Hospital

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 volunteers

Qualifiers

Adults aged 18 years or more

Disqualifiers

Incapabability of giving informed consent

Withdrawal of informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 10 MG

    Drug

    Once daily

  • Dapagliflozin 10 MG

    Drug

    Once daily

Treatment groups

17,200 Participants
are divided into 2 treatment groups
Group A: Empagliflozin 10 MGOther 1 intervention
Group B: Dapagliflozin 10 MGOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

All-cause mortality

Time frame
Up to 24 months
2

Hospitalization for heart failure

Time frame
Up to 24 months
3

Hospitalization for myocardial infarction

Time frame
Up to 24 months
4

Hospitalization for ischemic stroke

Time frame
Up to 24 months

Other outcomes

1

Hospitalization for ketoacidosis

Safety outcome

Time frame
Up to 24 months
2

Hospitalization for limb amputation

Safety outcome

Time frame
Up to 24 months
3

Hospitalization for genitourinary infection

Safety outcome

Time frame
Up to 24 months
4

Hospitalization for fracture

Safety outcome

Time frame
Up to 24 months

Sponsors and contacts

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