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New treatment option for Type 2 Diabetes Mellitus (T2DM)
Official title Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.
ClinicalTrials.gov ID: NCT07026539
What this study is testing
What is Finerenone (BAY 94-8862)?
Finerenone (BAY 94-8862) is an investigational medicine, given as an once-daily, being studied as a potential treatment for type 2 diabetes mellitus (t2dm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The global prevalence of diabetes is increasing substantially. Around 40 % of patients with type 2 diabetes develop chronic kidney disease.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age above 18 years.
- Diagnosis of type 2 diabetes according to the World Health Organization definition.
- Current treatment with a SGLT2-I1 at maximally tolerated dose.
- Current treatment with an ACE inhibitor or an ARB1 at maximally tolerated dose.
- Plasma potassium level of 4.8 mmol/L or less at the time of screening.
You likely can't join if
- Inability to give informed consent.
- Severe renal disease with eGFR \<25 ml/min/1.73m2.
- Severe hepatic disease (plasma ALAT above 3 x upper limit of normal).
- Active cancer diagnosis other than basal cell carcinoma.
- Treatment with systemic steroids at time of randomization.
- Bariatric surgery within 2 years or other gastrointestinal surgeries that induce chronic malabsorption.
See the full eligibility criteria
- Age above 18 years.
- Diagnosis of type 2 diabetes according to the World Health Organization definition.
- Current treatment with a SGLT2-I1 at maximally tolerated dose.
- Current treatment with an ACE inhibitor or an ARB1 at maximally tolerated dose.
- Plasma potassium level of 4.8 mmol/L or less at the time of screening.
- CKD defined as eGFR ≥25 ml/min/1.73 m2 and albuminuria (UACR between 30-5000 mg/g).
- Speak and understand Danish fluently.
- Inability to give informed consent.
- Severe renal disease with eGFR \<25 ml/min/1.73m2.
- Severe hepatic disease (plasma ALAT above 3 x upper limit of normal).
- Active cancer diagnosis other than basal cell carcinoma.
- Treatment with systemic steroids at time of randomization.
- Bariatric surgery within 2 years or other gastrointestinal surgeries that induce chronic malabsorption.
- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake.
- Chronic or acute pancreatitis.
- Pregnancy or breastfeeding (see pregnancy below).
- Poorly controlled medical condition, e.g. congestive heart failure (New York Heart Association III-IV or EF ≤ 40%), recent (within 3 months) stroke or acute myocardial infarction or any other condition that in the...
- Allergy to finerenone or any of the excipients contained in the drug.
- Current systemic treatment with strong inhibitors of CYP3A4 (e.g. itraconazol, ketoconazole, ritonavir, cobicistat, clarithromycin) or strong inducers of CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital).
- Current treatment with other MRAs (e.g. spironolactone, eplerenone etc.).
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption.
- Addison's disease.
- Contraindications to MRI.
- Previous renal or heart transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.