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Study on Heart Health in Type 2 Diabetes Patients Using Semaglutide and Dapagliflozin Combination

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with type 2 diabetes, a condition where the body struggles to regulate blood sugar levels effectively. The study aims to explore the potential benefits of a treatment strategy that involves a heart CT scan, which is a special imaging test that helps visualize the heart and its blood vessels. The trial will use several medications, including Ozempic (available in 0.25 mg, 0.5 mg, and 1 mg doses), which is a solution for injection containing the active substance semaglutide. Other medications involved in the study are Nitrolingual Pumpspray, a sublingual spray containing glyceryl trinitrate, Ivabradin Medical Valley, a film-coated tablet with ivabradine, Forxiga, a film-coated tablet containing dapagliflozin, Iomeron, a solution for injection with iomeprol, Seloken, a solution for injection containing metoprolol tartrate, and Atenolol Orifarm, a tablet with atenolol.

The purpose of the study is to evaluate if using a heart CT scan can provide cardiovascular benefits for patients with type 2 diabetes who do not have known heart disease. Participants will be randomly assigned to receive either the treatment strategy based on the heart CT scan or a standard treatment approach. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study will monitor the rates of cardiovascular events such as heart attacks, strokes, and heart-related deaths, as well as other health outcomes like overall mortality and kidney failure.

The trial will last for several years, with participants undergoing regular check-ups and assessments to track their health and any changes in their condition. The study will also collect information on the quality of life and patient-reported outcomes to understand the broader impact of the treatment strategy. By the end of the study, researchers hope to determine if the heart CT scan-based treatment approach offers significant benefits for managing type 2 diabetes and preventing heart-related complications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening
Upon joining the study, you will undergo an initial screening process. This involves a heart CT scan to assess your heart health. The purpose is to identify any subclinical coronary artery disease, which means heart disease that is not yet causing symptoms.
Step 2
Medication administration
If eligible, you will be assigned a treatment plan that may include medications. These medications could be semaglutide administered as a subcutaneous injection using a pre-filled pen, with dosages of 0.25 mg, 0.5 mg, or 1 mg. The frequency and duration of administration will be determined by the study protocol.
Other medications may include glyceryl trinitrate as a sublingual spray, ivabradine as a 5 mg film-coated tablet, dapagliflozin as a 10 mg film-coated tablet, iomeprol as an injection, metoprolol tartrate as an injection, and atenolol as a 50 mg tablet. The specific medications and their administration routes will be based on your individual treatment plan.
Step 3
Ongoing monitoring
Throughout the trial, your health will be closely monitored. This includes regular check-ups and assessments to track your response to the treatment. You may be asked to complete questionnaires, such as the EQ-5D, to report on your health and quality of life.
Step 4
End of trial
The trial is expected to conclude by September 2028. At the end of the trial, your overall health and any changes in your condition will be evaluated. The results will contribute to understanding the cardiovascular benefits of the treatment strategy.

Who can join the trial?

4 criteria

You must have a new or previous diagnosis of Type 2 diabetes according to the World Health Organization (WHO).
If you are a man, you must be between the ages of 55 and 69 years.
If you are a woman, you must be between the ages of 60 and 74 years.
You must sign a declaration of consent, which means you agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

Patients with **Type 2 diabetes** can participate, but those with known **cardiovascular disease** cannot. **Cardiovascular disease** refers to conditions affecting the heart and blood vessels.
Participants must be within the specified age range, which is not detailed here.
Both **male** and **female** participants are eligible.
Participants should not belong to a **vulnerable population**. This typically means groups that might need special protection, like children or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Hillerod Hospital
Verified
Hillerød, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Heart CT Scan is a special type of X-ray test that takes detailed pictures of your heart and its blood vessels. In this trial, the heart CT scan is used to check for any hidden heart problems in patients with type 2 diabetes who do not have known heart disease. The goal is to see if using this scan can help doctors find heart issues early and decide on the best treatment to prevent future heart problems.

What is already known about the treatment

Heart CT Scan-Based Treatment Strategy – This treatment strategy involves using a heart CT scan to guide the management of patients with type 2 diabetes who do not have known cardiovascular disease. The goal is to assess whether this approach can provide cardiovascular benefits. The heart CT scan is a non-invasive imaging method that helps visualize the coronary arteries to detect any subclinical coronary artery disease. This strategy is currently being evaluated in clinical trials, and its effectiveness is still under investigation. The main therapeutic indication is to potentially reduce cardiovascular risk in type 2 diabetes patients by identifying and addressing early signs of coronary artery disease.

Investigated diseases

Type 2 diabetes – Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, nerves, and heart. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As it progresses, individuals may experience more severe symptoms and complications related to prolonged high blood sugar levels. Managing blood sugar levels is crucial to slowing the progression of the disease and preventing complications.