Study on Reducing Cardiovascular Disease in Type 1 Diabetes Patients Using Finerenone and Semaglutide

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What is this study about?

This clinical trial is focused on studying new treatments for reducing cardiovascular disease in individuals with Type 1 diabetes. The study will explore the effects of a medication called Finerenone, also known by its code name BAY 94-8862, which is taken as a film-coated tablet. Additionally, the study will involve the use of Ozempic, a solution for injection that contains the active substance Semaglutide. Another medication involved in the study is Sotagliflozin, which is also taken as a film-coated tablet.

The purpose of the study is to test a strategy of intensified care for people with Type 1 diabetes who are at high risk of cardiovascular disease. This involves setting ambitious treatment goals compared to standard care. The study will also investigate the safety and effectiveness of 40 mg of Finerenone in reducing the risk of cardiovascular death and hospitalization for heart failure. Participants will receive either the new treatment strategy or standard care, and some may receive a placebo. The study will last for a period of 60 weeks, during which participants will be monitored for any major adverse cardiovascular events, such as heart attacks or strokes, and hospitalizations for heart failure.

Throughout the study, researchers will assess whether the new treatment approach is more effective than standard care in preventing these cardiovascular events. They will also evaluate the impact on kidney function and overall mortality. The study aims to provide valuable insights into the potential benefits of these treatments for individuals with Type 1 diabetes who are at risk of cardiovascular complications.

1 joining the study

Upon joining the study, the participant will have provided written informed consent. This indicates understanding and agreement to participate in the trial.

Participants must be at least 40 years old, have had type 1 diabetes for over 10 years, and meet specific health criteria such as chronic kidney disease or a history of heart disease.

2 initial assessment

An initial assessment will be conducted to evaluate the participant’s health status and eligibility for the trial. This may include medical history review and physical examinations.

3 treatment phase

Participants will receive a multifactorial intervention aimed at reducing cardiovascular disease risk. This includes the administration of medications such as semaglutide and finerenone.

Semaglutide is administered as a subcutaneous injection, available in doses of 0.25 mg, 0.5 mg, and 1 mg.

Finerenone is provided in the form of oral film-coated tablets, with a dosage of 40 mg.

4 monitoring and follow-up

Participants will be monitored regularly to assess the effectiveness and safety of the treatment. This includes tracking any major adverse cardiovascular events and hospitalizations for heart failure.

Regular check-ups will be scheduled to evaluate the participant’s health and adjust treatment as necessary.

5 completion of the study

The study is expected to conclude by June 2029. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Must provide written consent to participate in the study.
Must be a male or female who is 40 years old or older and has been diagnosed with Type 1 diabetes for more than 10 years. Type 1 diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
Must have one of the following conditions:
- Chronic kidney disease, which means the kidneys are not working as well as they should. This is shown by a specific test result (UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2).
- A history of ischemic heart disease, which includes having had a heart attack, stroke, or chest pain (angina).
- A history of heart failure, which means the heart is not pumping blood as well as it should.
- Obesity grade 2 or 3, which means having a body mass index (BMI) over 35.
- A 10-year risk of cardiovascular disease (CVD) greater than 10% according to a specific risk assessment tool.
Females who can have children must use highly effective birth control methods during the study and for at least 2 months after stopping the study drug. These methods include:
- Intrauterine device (IUD) or hormonal methods that prevent ovulation, such as pills, implants, patches, vaginal rings, or injections.
- Alternatively, they must be in menopause (no menstrual periods for at least one year), have had both ovaries removed, or have been surgically sterilized or had a hysterectomy at least 12 months before the study.
Must be able to communicate with the study doctor and understand the consent form.
For those participating in the CGM sub-study, they must already be using a Continuous Glucose Monitor (CGM) as part of their regular diabetes care. A CGM is a device that tracks blood sugar levels throughout the day and night.

Who Cannot Join the Study?

Individuals who do not have Type 1 diabetes cannot participate. Type 1 diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
Participants must be at high risk of cardiovascular disease (CVD). Cardiovascular disease refers to conditions affecting the heart and blood vessels.
Participants should be at risk of cardiovascular death or hospitalization for heart failure (HHF). Heart failure is when the heart does not pump blood as well as it should.
Individuals outside the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Both males and females are eligible, so gender is not a reason for exclusion.
Participants must not belong to a vulnerable population. Vulnerable populations include groups that may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country
Regionshospitalet Silkeborg	Silkeborg	Denmark
Regionshospitalet Viborg	Viborg	Denmark
Steno Diabetes Center North Denmark	Aalborg	Denmark
Odense University Hospital	Odense	Denmark
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Steno Diabetes Center Copenhagen	Herlev	Denmark
Nykoebing F Sygehus	Nykobing	Denmark
Region Midtjylland	Randers	Denmark
Sjællands Universitetshospital	Koege	Denmark
Holbæk sygehus	Holbæk	Denmark
Rsqmjb Mvotoenfjqm	Herning	Denmark
Sawfo Deypdugj Cbwdtn Asceqy	Aarhus	Denmark
Hyjxuamp Hycyanyu	Hvidovre	Denmark
Hixpherv Hastbqow	Hillerød	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	27.06.2024

Trial locations

Investigated drugs:

Finerenone is a medication being tested in this trial for its safety and effectiveness in people with type 1 diabetes who are at risk of cardiovascular death and hospitalization due to heart failure. The study aims to see if this medication can help reduce these risks.

Investigated diseases:

Type 1 diabetes mellitus

Type 1 diabetes – Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in adolescence or early adulthood but can develop at any age. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. This leads to high blood sugar levels, which can cause symptoms like increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed properly, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. Management involves monitoring blood sugar levels, insulin therapy, diet, and lifestyle changes.

Trial ID:

2023-505794-32-04

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing Cardiovascular Disease in Type 1 Diabetes Patients Using Finerenone and Semaglutide

What is this study about?

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