Study on the Effects of Semaglutide, Dapagliflozin, and Metformin in Patients with Coronary Artery Disease and Prediabetes

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What is this study about?

This clinical trial is focused on studying the effects of certain medications on patients with coronary artery disease and prediabetes. Coronary artery disease is a condition where the blood vessels supplying the heart become narrowed or blocked, while prediabetes is a state where blood sugar levels are higher than normal but not yet high enough to be classified as diabetes. The study will involve the use of medications such as semaglutide (known by the brand name Rybelsus), dapagliflozin (known by the brand name Forxiga), and metformin (known by the brand name Formetic). These medications are taken orally in tablet form.

The purpose of the study is to compare the effectiveness of these medications in slowing down or reversing the buildup of plaque in the arteries of the heart, which is a key factor in coronary artery disease. The study will last for 24 months, during which participants will receive one of the medications along with advice on diet and lifestyle changes. The progress of the disease will be monitored using a special type of X-ray called computed tomography (CT), which provides detailed images of the heart and its blood vessels.

Participants will be randomly assigned to receive either semaglutide, dapagliflozin, metformin, or a placebo. The study aims to observe how these treatments affect the progression of coronary artery disease and other health factors such as weight, blood pressure, and cholesterol levels. The results will help determine which medication is most effective in managing coronary artery disease in patients with prediabetes.

1 Joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of coronary artery disease, and prediabetes.

A core CT scan is required to be performed within three months of joining the study to assess coronary artery condition.

2 Initial assessment and randomization

Participants undergo an initial assessment to document baseline health status, including blood glucose levels and cardiovascular risk factors.

Participants are randomly assigned to one of the treatment groups to receive either metformin hydrochloride, semaglutide, or dapagliflozin.

3 Treatment phase

Participants receive their assigned medication orally. The medications include Formetic 500 mg (metformin), Rybelsus 14 mg, Rybelsus 3 mg, Rybelsus 7 mg (semaglutide), and Forxiga 10 mg (dapagliflozin).

The treatment continues alongside optimal diet and lifestyle modifications for a duration of 24 months.

4 Regular monitoring

Participants attend regular follow-up visits to monitor health status, medication adherence, and any side effects.

Health parameters such as blood glucose levels, weight, and cardiovascular health are assessed periodically.

5 Final assessment

At the end of the 24-month treatment period, a final assessment is conducted to evaluate the impact of the treatment on coronary artery disease progression.

The primary outcome is measured by changes in coronary plaque volume as assessed by CT scans.

Who Can Join the Study?

Age between 18 and 80 years old.
Diagnosed with coronary artery disease, which means there is a narrowing of at least 20% in the heart’s blood vessels, detected in a special heart scan or after a procedure to open up the blood vessels.
A heart scan of good quality must be done within 3 months before joining the study.
Have prediabetes, which means blood sugar levels are higher than normal but not high enough to be diabetes. This can be shown by specific blood tests done during or shortly before the study.
Have been managing heart health risks, like diet and lifestyle, in a stable way for at least 4 weeks.
Willing and able to give consent to participate in the study, meaning you agree to join after understanding what it involves.
Be able and willing, according to the study doctor, to follow all the study’s requirements.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any of the study medications.
Individuals with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication or lifestyle changes.
Patients with severe liver disease, which affects how the liver functions.
Individuals with severe kidney disease, which affects how the kidneys work.
Patients who are pregnant or breastfeeding.
Individuals who have participated in another clinical trial within the last 30 days.
Patients with a history of drug or alcohol abuse within the past year.
Individuals with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.11.2024

Trial locations

Investigated drugs:

Semaglutide is an oral medication used in this study to evaluate its effectiveness in reducing atherosclerosis in patients with coronary artery disease and prediabetes. It works by mimicking a hormone in the body that helps regulate blood sugar levels and may have beneficial effects on heart health.

Dapagliflozin is another medication being tested in the trial. It is an SGLT-2 inhibitor that helps lower blood sugar levels by causing the kidneys to remove sugar from the body through urine. This study aims to see if it can also help reduce the progression of coronary artery disease in patients with prediabetes.

Metformin is a commonly used medication for managing blood sugar levels in people with type 2 diabetes. In this trial, it serves as a comparison to evaluate the effectiveness of the other medications in reducing atherosclerosis in patients with coronary artery disease and prediabetes.

Investigated diseases:

Coronary artery disease

Coronary Artery Disease – This condition involves the narrowing or blockage of the coronary arteries, usually due to a buildup of cholesterol and fatty deposits called plaques. Over time, these plaques can harden or rupture, leading to reduced blood flow to the heart muscle. As the disease progresses, it can cause chest pain or discomfort, known as angina, especially during physical activity or stress. If a plaque ruptures, it can lead to a heart attack, which occurs when blood flow to a part of the heart is completely blocked. The progression of coronary artery disease can vary, with some individuals experiencing rapid changes while others may have a more gradual development of symptoms.

Prediabetes – This condition is characterized by blood sugar levels that are higher than normal but not yet high enough to be classified as type 2 diabetes. It often develops gradually and may not present noticeable symptoms. Over time, if lifestyle changes are not made, prediabetes can progress to type 2 diabetes, increasing the risk of heart disease and other complications. The condition is often identified through routine blood tests that measure glucose levels. Lifestyle modifications, such as improved diet and increased physical activity, can help prevent or delay the progression to diabetes.

Coronary Atherosclerosis – This disease involves the buildup of fatty deposits, or plaques, within the walls of the coronary arteries. These plaques can cause the arteries to narrow and stiffen, reducing blood flow to the heart muscle. As the condition progresses, it can lead to symptoms such as chest pain or discomfort, especially during exertion. If a plaque ruptures, it can result in a blood clot that may completely block the artery, potentially causing a heart attack. The progression of coronary atherosclerosis can vary among individuals, influenced by factors such as lifestyle and genetic predisposition.

Coronary Heart Disease – This condition is a result of the narrowing or blockage of the coronary arteries due to plaque buildup. It can lead to reduced blood flow to the heart, causing symptoms like chest pain or discomfort, particularly during physical activity. Over time, the disease can progress to more severe complications, such as heart attacks, if the blood supply to the heart is significantly reduced or blocked. The progression of coronary heart disease can be influenced by factors such as diet, exercise, and other health conditions. Regular monitoring and lifestyle changes can help manage the condition and slow its progression.

Trial ID:

2023-508525-27-00

Protocol code:

CSDS.IV/VIII/2023

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Semaglutide, Dapagliflozin, and Metformin in Patients with Coronary Artery Disease and Prediabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?