NCT06642272 A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
| NCT ID | NCT06642272 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Herlev and Gentofte Hospital |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 17,200 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 17,200 participants in total. It began in 2024-10-10 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or more Exclusion Criteria: * Incapabability of giving informed consent * Withdrawal of informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06642272 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06642272 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06642272 currently recruiting?
Yes, NCT06642272 is actively recruiting participants. Contact the research team at morten.schou.04@regionh.dk for enrollment information.
Where is the NCT06642272 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark, Herlev, Denmark, Herlev, Denmark and 8 additional locations.
Who is sponsoring the NCT06642272 clinical trial?
NCT06642272 is sponsored by Herlev and Gentofte Hospital. The trial plans to enroll 17,200 participants.
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