Actively Recruiting
A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
Led by Herlev and Gentofte Hospital · Updated on 2024-11-05
17200
Participants Needed
12
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the comparative effectiveness of two drugs, empagliflozin and dapagliflozin, for treating type 2 diabetes, chronic kidney disease, and heart failure. This phase 4 clinical trial aims to understand how these medications impact important health outcomes including death, heart-related hospitalizations, and kidney problems. Participants prescribed either empagliflozin 10 mg or dapagliflozin 10 mg once daily as part of their usual care will be included. Treatment assignment is randomized automatically through electronic health records based on the time of day, allowing comparison of these two drugs in real-life clinical settings. During the study, researchers will track the time to the first occurrence of events such as death, hospitalizations for heart failure, heart attack, stroke, and worsening kidney disease up to 24 months. Secondary outcomes include other heart-related hospitalizations. Participants will be monitored through their medical records over this period to observe these health events and treatment effects.
CONDITIONS
Brief Title
A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or more
You will not qualify if you...
- Incapability of giving informed consent
- Withdrawal of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants take either Empagliflozin or Dapagliflozin once daily as assigned.
Trial Site Locations
Total: 12 locations
1
Bispebjerg Hospital
Copenhagen, Denmark
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark
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3
Herlev and Gentofte Hospital
Herlev, Denmark
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4
Steno Diabetes Center Copenhagen
Herlev, Denmark
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5
Nordsjællands Hospital
Hillerød, Denmark
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6
Holbæk Sygehus
Holbæk, Denmark
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7
Hvidovre Hospital
Hvidovre, Denmark
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8
Sjællands Universitetshospital
Køge, Denmark
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9
Nykøbing F. Sygehus
Nykøbing Falster, Denmark
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10
Sjællands Universitetshospital
Roskilde, Denmark
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11
Bornholms Hospital
Rønne, Denmark
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12
Slagelse Sygehus
Slagelse, Denmark
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Research Team
M
Morten Schou, Professor
D
Daniel M. Christensen, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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