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NCT Number: NCT06642272

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

Recruiting

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or more

Exclusion criteria

  • Incapabability of giving informed consent
  • Withdrawal of informed consent

Treatment and study plan

Empagliflozin 10 MG

Drug

Once daily

Dapagliflozin 10 mg

Drug

Once daily

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.

    Time frame: Up to 24 months

    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

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

  5. Incident or worsening nephropathy

    Time frame: Up to 24 months

    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

  6. Hospitalization for coronary revascularization

    Time frame: Up to 24 months

  7. Hospitalization for unstable angina

    Time frame: Up to 24 months

Other outcomes

  1. Hospitalization for ketoacidosis

    Time frame: Up to 24 months

    Safety outcome

  2. Hospitalization for limb amputation

    Time frame: Up to 24 months

    Safety outcome

  3. Hospitalization for genitourinary infection

    Time frame: Up to 24 months

    Safety outcome

  4. Hospitalization for fracture

    Time frame: Up to 24 months

    Safety outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel M. Christensen, MD, PhD

CONTACT

[email protected]

004526248546

Morten Schou, Professor

CONTACT

[email protected]

004540523920

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Acronym: APPLE TREE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 15, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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