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 range18 Years

SexALL

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…

What they're measuring

Questionnaire results

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Remote urine collection

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Remote blood pressure measurements

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Remote body weight measurements

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Treatment adherence

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Trial details

NCT IDNCT06094920

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-24

View on ClinicalTrials.gov More Diabetes Mellitus Type 2 With Proteinuria trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Questionnaire results

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Remote urine collection

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Remote blood pressure measurements

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Remote body weight measurements

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.

Treatment adherence

Timeframe: Will be assessed within 6 months and reported within 1 year after conclusion of the study.