Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a … (NCT06094920) | Clinical Trial Compass
CompletedPhase 4
Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial
Netherlands12 participantsStarted 2024-07-29
Plain-language summary
The goal of this clinical trial is to determine the feasibility of remote clinical trial conduct in patients with type 2 diabetes and elevated albuminuria. The main questions it aims to answer are:
* What is the feasibility (and advantages) of remote clinical trial conduct with multiple medications in patients with type 2 diabetes and elevated albuminuria?
* What is the individual response to the SGLT2 inhibitor empagliflozin in urine albumin-creatinine ratio?
* What is the individual response to the SGLT2 inhibitor empagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose?
* Can suboptimal treatment responses to empagliflozin be overcome by the addition or substitution with finerenone?
Participants will collect all study data in the comfort of their own environments
* First-morning void urine samples
* Capillary blood samples
* Blood pressure
* Body weight
Participants will be assigned to a 3-week treatment period with empagliflozin 10 mg/day. Based on the albuminuria response after 2 weeks, participants will be allocated to one of three treatment regimens after the 3-week treatment period with empagliflozin:
* Continue empagliflozin for 4 more weeks (good response).
* Continue empagliflozin for 4 more weeks and add finerenone 10 or 20 mg will be added for 4 weeks (moderate response).
* Stop empagliflozin and start finerenone 10 or 20 mg for 4 weeks (no response)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of type 2 diabetes
* UACR \>4.5 mg/mmol (\>40 mg/g) and ≤300 mg/mmol (≤2655 mg/g)
* eGFR ≥25 mL/min/1.73m2
* On a stable dose of an ACE inhibitor/ARB if tolerated
* Willing to sign informed consent.
* Proficiency in the Dutch language
Exclusion Criteria:
* Diagnosis of type 1 diabetes
* Already treated with any SGLT2 inhibitor or MRA
* Unable to monitor blood pressure or body weight or handle digital technologies.
* Heart failure New York Heart Association (NYHA) Class II to IV requiring MRA treatment
* Acute coronary syndrome event within 6 months
* Serum potassium \>5 mmol/L repeat value after repeated measurement
* Evidence of severe hepatic impairment determined by any of one: ALT or AST values exceeding 3 times ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt.
* Active pregnancy or breastfeeding
* History of kidney or liver transplant
* Unstable or rapidly progressing renal disease.
* Active malignancy
* Suggestive evidence of adrenal insufficiency
* History of severe hypersensitivity or contraindications to any SGLT2 inhibitor or MRA
* Uncontrolled arterial hypertension (mean sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
* Histo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Questionnaire results
Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.
2
Remote urine collection
Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.
3
Remote blood pressure measurements
Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.
4
Remote body weight measurements
Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.
5
Treatment adherence
Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.