MedDataX Logo

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

NCT ID: NCT06642272

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

17200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure

NCT05042973

Obesity Heart Failure
COMPLETED PHASE2

Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin.

NCT06374043

Diabetes Mellitus, Type 2 Diabetes Mellitus Type 2 With Proteinuria Diabetes Mellitus +7 more
COMPLETED PHASE4

dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

NCT06072326

Type 1 Diabetes Mellitus With Diabetic Nephropathy
NOT_YET_RECRUITING PHASE2

Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease (EMPA-PKD)

NCT06391450

Autosomal Dominant Polycystic Kidney
ACTIVE_NOT_RECRUITING PHASE4

Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects

NCT03485092

Heart Failure Diabetes Mellitus
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Heart Failure Chronic Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Treatment assignment will be blinded to the statistician analysing the trial data.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Empagliflozin 10 MG

Head-to-head comparator

Group Type OTHER

Empagliflozin 10 MG

Intervention Type DRUG

Once daily

Dapagliflozin 10 MG

Head-to-head comparator

Group Type OTHER

Dapagliflozin 10 MG

Intervention Type DRUG

Once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empagliflozin 10 MG

Once daily

Intervention Type DRUG

Dapagliflozin 10 MG

Once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults aged 18 years or more

Exclusion Criteria

* Incapabability of giving informed consent
* Withdrawal of informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Mølager Christensen

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Herlev and Gentofte Hospital

Herlev, , Denmark

Site Status RECRUITING

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Site Status RECRUITING

Nordsjællands Hospital

Hillerød, , Denmark

Site Status RECRUITING

Holbæk Sygehus

Holbæk, , Denmark

Site Status RECRUITING

Hvidovre Hospital

Hvidovre, , Denmark

Site Status RECRUITING

Sjællands Universitetshospital

Køge, , Denmark

Site Status RECRUITING

Nykøbing F. Sygehus

Nykøbing Falster, , Denmark

Site Status RECRUITING

Sjællands Universitetshospital

Roskilde, , Denmark

Site Status RECRUITING

Bornholms Hospital

Rønne, , Denmark

Site Status RECRUITING

Slagelse Sygehus

Slagelse, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Morten Schou, Professor

Role: CONTACT

[email protected]
004540523920

Daniel M. Christensen, MD, PhD

Role: CONTACT

[email protected]
004526248546

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Morten Schou, Professor

Role: primary

[email protected]
004540523920

Daniel M. Christensen, MD, PhD

Role: backup

[email protected]
004526248546

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2401312

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Head-to-head Comparison of Empagliflozin and Dapagliflozin
NCT03748810 COMPLETED
Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial
NCT06094920 ENROLLING_BY_INVITATION PHASE4
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
NCT03152552 TERMINATED PHASE2
Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria
NCT04061200 UNKNOWN PHASE4
A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to Balcinrenone and Placebo on Body Fluid and Electrolyte Handling and Energy Metabolism in Participants Over 50 Years of Age With Chronic Kidney Disease.
NCT05884866 RECRUITING PHASE2
REGROUP: Renohemodynamic Effects empaGliflozin in vaRiOUs Populations
NCT04243850 WITHDRAWN PHASE4
Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
NCT00663260 COMPLETED PHASE2/PHASE3
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
NCT06483074 RECRUITING PHASE2
Renohemodynamic Effects of Combined empagliflOzin and LosARtan
NCT04238702 COMPLETED PHASE4
Dapagliflozin Treatment in Type 2 Diabetes
NCT04620590 COMPLETED PHASE4
A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients
NCT02616666 ACTIVE_NOT_RECRUITING PHASE4
A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
NCT06642623 RECRUITING PHASE4
A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI)
NCT07311551 NOT_YET_RECRUITING PHASE4
Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
NCT07273838 NOT_YET_RECRUITING PHASE2
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
NCT06030843 RECRUITING PHASE2/PHASE3
Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes
NCT03132181 COMPLETED PHASE2
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
NCT06110130 RECRUITING PHASE4
Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure
NCT04071626 TERMINATED PHASE4
Empagliflozin Reduces Progression of Diabetic Retinopathy in Patients With High Risk of Diabetic Macular Edema
NCT02985242 TERMINATED PHASE4
Renal Impairment in Type 2 Diabetic Subjects
NCT00554450 COMPLETED PHASE1
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
NCT01370005 COMPLETED PHASE3
Renoprotective Effects of Dapagliflozin in Type 2 Diabetes
NCT02682563 COMPLETED PHASE4
Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure
NCT05392764 RECRUITING PHASE3
Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease
NCT05465317 COMPLETED
A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
NCT03492580 COMPLETED