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

Phase 4

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Heart Failure; Chronic Kidney Diseases
• Interventions: Drug: Empagliflozin 10 MG; Drug: Dapagliflozin 10 MG

• Registration Number: NCT06642272
• Lead Sponsor: Herlev and Gentofte Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-12
• Study First Posted: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17200

Inclusion Criteria

• Adults aged 18 years or more

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Exclusion Criteria

• Incapabability of giving informed consent
• Withdrawal of informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin 10 MG	Empagliflozin 10 MG	Head-to-head comparator
Dapagliflozin 10 MG	Dapagliflozin 10 MG	Head-to-head comparator

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
All-cause mortality	Up to 24 months
Hospitalization for heart failure	Up to 24 months
Hospitalization for myocardial infarction	Up to 24 months
Hospitalization for ischemic stroke	Up to 24 months
Incident or worsening nephropathy	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
Hospitalization for coronary revascularization	Up to 24 months
Hospitalization for unstable angina	Up to 24 months

Trial Locations

Locations (11)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Steno Diabetes Center Copenhagen; 🇩🇰 Herlev, Denmark

Nordsjællands Hospital; 🇩🇰 Hillerød, Denmark

Holbæk Sygehus; 🇩🇰 Holbæk, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Sjællands Universitetshospital; 🇩🇰 Roskilde, Denmark

Nykøbing F. Sygehus; 🇩🇰 Nykøbing Falster, Denmark

Bornholms Hospital; 🇩🇰 Rønne, Denmark

Slagelse Sygehus; 🇩🇰 Slagelse, Denmark

Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark