NCT06642272

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,200

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
32mo left

Started Oct 2024

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Oct 2024Dec 2028

First Submitted

Initial submission to the registry

October 10, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

4.2 years

First QC Date

October 10, 2024

Last Update Submit

November 1, 2024

Conditions

Diabetes Mellitus, Type 2Heart FailureChronic Kidney Diseases

Outcome Measures

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

    Up to 24 months

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (4)

  • Hospitalization for ketoacidosis

    Up to 24 months

  • Hospitalization for limb amputation

    Up to 24 months

  • Hospitalization for genitourinary infection

    Up to 24 months

  • +1 more other outcomes

Study Arms (2)

Empagliflozin 10 MG

OTHER

Head-to-head comparator

Drug: Empagliflozin 10 MG

Dapagliflozin 10 MG

OTHER

Head-to-head comparator

Drug: Dapagliflozin 10 MG

Interventions

Empagliflozin 10 MGDRUG

Once daily

Empagliflozin 10 MG
Dapagliflozin 10 MGDRUG

Once daily

Dapagliflozin 10 MG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or more

You may not qualify if:

  • Incapabability of giving informed consent
  • Withdrawal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Bispebjerg Hospital

Copenhagen, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Herlev and Gentofte Hospital

Herlev, Denmark

RECRUITING

Steno Diabetes Center Copenhagen

Herlev, Denmark

RECRUITING

Nordsjællands Hospital

Hillerød, Denmark

RECRUITING

Holbæk Sygehus

Holbæk, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Denmark

RECRUITING

Sjællands Universitetshospital

Køge, Denmark

RECRUITING

Nykøbing F. Sygehus

Nykøbing Falster, Denmark

RECRUITING

Sjællands Universitetshospital

Roskilde, Denmark

RECRUITING

Bornholms Hospital

Rønne, Denmark

RECRUITING

Slagelse Sygehus

Slagelse, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart FailureRenal Insufficiency, Chronic

Interventions

empagliflozindapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Morten Schou, Professor

CONTACT

004540523920morten.schou.04@regionh.dk

Daniel M. Christensen, MD, PhD

CONTACT

004526248546dmc@dadlnet.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Treatment assignment will be blinded to the statistician analysing the trial data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

October 10, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations

DK(12)