Comparing two diabetes medications, empagliflozin and dapagliflozin
A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
This study is testing which diabetes medication, empagliflozin or dapagliflozin, works better for people with type 2 diabetes, chronic kidney disease, and heart failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 17200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 12 sites (Copenhagen and 11 other locations) |
| Trial ID | NCT06642272 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of empagliflozin and dapagliflozin in treating patients with type 2 diabetes, chronic kidney disease, and heart failure. Patients who are prescribed either medication as part of their routine care will be included, with treatment assignments randomized through electronic health record systems based on the time of day. This pragmatic approach allows for real-world data collection and analysis of outcomes in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are being prescribed empagliflozin or dapagliflozin.
Not a fit: Patients who are unable to provide informed consent or who withdraw consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which medication is more effective for patients with diabetes and related conditions, leading to improved treatment strategies.
How similar studies have performed: Other studies have explored the effectiveness of these medications, but this specific approach using electronic health records for cluster randomization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or more Exclusion Criteria: * Incapabability of giving informed consent * Withdrawal of informed consent
Where this trial is running
Copenhagen and 11 other locations
- 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)
Study contacts
- Study coordinator: Morten Schou, Professor
- Email: morten.schou.04@regionh.dk
- Phone: 004540523920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.