Finerenone treatment for cardiovascular issues in diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of finerenone, a mineralocorticoid receptor antagonist, in treating cardiovascular autonomic neuropathy (CAN) in patients with type 2 diabetes. It is a double-blind, randomized, placebo-controlled trial involving 100 participants over 78 weeks. The study aims to determine if finerenone can improve symptoms of early-stage CAN and assess its impact on other types of neuropathy. Participants will be randomly assigned to receive either finerenone or a placebo.

Why it matters

Who can join: the full rules

To be included in this study the participants must fulfill the following inclusion criteria.

* Given informed consent
* Type 2 diabetes defined by WHO criteria
* Aged 40 ≥ at inclusion
* Pathological E/I ratio (Mean value of three measures)

Exclusion criteria Participants will be excluded in one or more of the following criteria are met.

* No CAN (no abnormal CARTs)
* Definite CAN (more than one abnormal CART)
* HbA1C \>100 mmol/L
* Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient's primary physician, who is not involved in this study, will determine if discontinuation is possible.
* Atrial fibrillation/flutter
* Congestive heart failure (NYHA class 3-4)
* History of cardiac arrhythmia
* Severe forms of respiratory disease including asthma and COPD
* Any nondiabetic cause of neuropathy
* All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A).
* Severe hepatic impairment
* Lactose intolerance
* Breastfeeding
* Nephropathy requiring dialysis
* Beta-blocker-use
* Hyperkalemia at screening visit (plasma potassium \>4.8 mmol/l)
* eGFR \< 25 ml/min/1.73m2
* Potassium plasma \> 4.8 mmol/l (at randomization)
* Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit
* Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit
* Have received chemotherapeutic treatment within last 12 months
* Grapefruit consumption that cannot be discontinued during the study period
* Inability to complete study protocol, assessed to investigator
* Not able to read, write and/or understand Danish

Where it's running

• Steno Diabetes Center Northern Denmark
  Gistrup, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Herlev, Denmark Not yet recruiting

Study contacts

• Principal investigator: Peter Rossing, Professor, MD — Steno Diabetes Center Copenhagen
• Study coordinator: Peter Rossing, Professor, MD
• Email: peter.rossing@regionh.dk
• Phone: +4530913383

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.