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

Herlev and Gentofte Hospital

Status and phase: Enrolling; Phase 4

Conditions: Chronic Kidney Diseases; Heart Failure; Diabetes Mellitus, Type 2

Treatments: Drug: Dapagliflozin 10 MG; Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06642272

2401312

Details and patient eligibility

About

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

Enrollment: 17,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or more

Exclusion criteria

• Incapabability of giving informed consent
• Withdrawal of informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17,200 participants in 2 patient groups

Empagliflozin 10 MG

Other group

Description:

Head-to-head comparator

Treatment:

Drug: Empagliflozin 10 MG

Dapagliflozin 10 MG

Other group

Description:

Head-to-head comparator

Treatment:

Drug: Dapagliflozin 10 MG