Study of dapagliflozin and semaglutide to reverse prediabetes to normal blood sugar levels in patients with coronary artery disease

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What is this study about?

This study looks at prediabetes and coronary artery disease. Prediabetes is a condition where blood sugar levels are higher than normal but not high enough to be called diabetes. Coronary artery disease is a condition where the blood vessels that supply the heart with oxygen and nutrients become narrowed or blocked. The study will use two medications: dapagliflozin, which is a tablet taken by mouth, and semaglutide, which is given as an injection under the skin. These are medications that lower blood sugar levels and have been shown to protect the heart.

The purpose of the study is to find out how many patients with coronary artery disease and prediabetes can return to normal blood sugar levels when treated with these blood sugar-lowering medications. The study will also look at whether patients with prediabetes have more problems with their eyes, kidneys, nerves, and liver compared to patients with normal blood sugar levels. During the study, patients will receive treatment for one year, and then they will be followed for another year to see if their blood sugar levels stay normal or if prediabetes comes back, or if they develop diabetes.

The study will measure blood sugar control using a blood test called HbA1c, which shows the average blood sugar level over the past few months. Other measurements will include kidney function tests, liver health markers, cholesterol levels, body weight, and waist size. The study will also check for complications that can affect the eyes, kidneys, and nerves, as well as a liver condition called MASLD, which is a buildup of fat in the liver. The study will compare patients who receive the blood sugar-lowering medications with those who receive standard care to see which approach is more effective in bringing blood sugar levels back to normal and preventing diabetes.

1 Baseline assessment and treatment assignment

At the beginning of the trial, your current health status will be assessed. This includes measurement of HbA1c, which is a blood test showing your average blood sugar levels over the past 2-3 months.

Based on your HbA1c level, you will be assigned to one of the treatment groups. If your HbA1c is between 42-47 mmol/mol (prediabetes range), you will receive either active medication or standard care. If your HbA1c is below 39 mmol/mol (normal blood sugar), you will be part of a comparison group.

Additional tests will be performed to check for complications affecting your eyes (retinopathy), kidneys (nephropathy), nerves (neuropathy), and liver (MASLD, which is fatty liver disease).

Your kidney function will be measured using eGFR (a calculation showing how well your kidneys filter blood) and cystatin-C (a protein that helps assess kidney function).

Blood tests will measure inflammation markers (hs-CRP), fat levels in your blood (lipid parameters), insulin production (c-peptide), insulin resistance (HOMA-IR), and liver health markers (Fib-4, CD163, PRO-C3).

Your weight and waist circumference will be measured.

A urine test will check the albumin-creatinine ratio, which indicates kidney health.

2 First year of treatment

If you are assigned to the active treatment group, you will receive two medications: dapagliflozin and semaglutide.

Dapagliflozin is taken by mouth (oral administration). The specific dosage and frequency will be determined by the trial protocol.

Semaglutide is administered as an injection under the skin (subcutaneous injection). The specific dosage and frequency will be determined by the trial protocol.

You will take these medications for one year.

If you are assigned to the conventional therapy group, you will continue with standard care without these additional medications.

During this year, regular follow-up visits will occur to monitor your health and response to treatment.

3 Assessment after one year

After completing one year of treatment, your HbA1c will be measured again to determine if your blood sugar levels have returned to normal (below 39 mmol/mol) or improved (below 42 mmol/mol).

All the tests performed at the beginning will be repeated, including kidney function tests, inflammation markers, liver health markers, and tests for complications affecting eyes, kidneys, nerves, and liver.

Your weight and waist circumference will be measured again.

The severity of fatty liver disease (MASLD) will be reassessed if applicable.

Changes in all measured parameters compared to the beginning of the trial will be calculated.

4 Second year of follow-up

After the first year of treatment ends, you will be followed for an additional year without the study medications.

During this second year, monitoring will continue to observe whether blood sugar levels remain normal, return to prediabetes levels, or progress to type 2 diabetes.

The trial will track whether prediabetes returns (HbA1c between 39-47 mmol/mol or 42-47 mmol/mol) or if type 2 diabetes develops.

This follow-up period allows assessment of the long-term effects of the one-year treatment.

5 End of trial participation

Your participation in the trial will conclude after the two-year period (one year of treatment plus one year of follow-up).

Final assessments will be completed to evaluate the overall outcomes of the treatment approach.

The trial is estimated to continue until October 2029, with recruitment beginning in November 2025.

Who Can Join the Study?

You must have chronic coronary syndrome, which means long-term heart problems caused by narrowed or blocked blood vessels that supply the heart, and this must be confirmed by special imaging tests of your heart arteries. If you have had a heart attack in the past, which is when blood flow to part of the heart muscle is blocked, at least 30 days must have passed between the heart attack and joining this study.
You must have prediabetes, which means your blood sugar levels are higher than normal but not high enough to be called diabetes. This is measured by a blood test called HbA1c, which shows your average blood sugar over the past few months, and your result must be between 42 and 47 mmol/mol. OR you must have normal blood sugar levels with an HbA1c result below 39 mmol/mol.
You must be between 18 and 80 years old.

Who Cannot Join the Study?

The study information provided does not list specific reasons why patients cannot participate in this clinical trial
If you are considering participating in a clinical trial, the research team will review your complete medical history to determine if you are eligible
Standard exclusion criteria, which are reasons a person cannot join a study, are typically determined by the research doctors but are not specified in the available information

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.11.2025

Trial locations

Investigated drugs:

Glucose-lowering drugs are medications that help reduce the amount of sugar (glucose) in your blood. In this trial, these medicines are being tested to see if they can help people with prediabetes return to normal blood sugar levels. These drugs are also known to protect the heart, which is important for patients who have coronary artery disease (blocked arteries in the heart).

Investigated diseases:

Coronary artery disease

Coronary artery disease – Coronary artery disease is a condition where the major blood vessels that supply the heart with oxygen and nutrients become damaged or diseased. This typically happens when cholesterol-containing deposits called plaques build up on the artery walls, making them narrow and stiff. As the disease progresses, the arteries become increasingly blocked, reducing blood flow to the heart muscle. This narrowing process, called atherosclerosis, develops gradually over many years. When the heart muscle doesn’t receive enough blood, it can cause chest pain or discomfort. The disease can affect one or more of the coronary arteries that wrap around the heart.

Prediabetes – Prediabetes is a condition where blood sugar levels are higher than normal but not yet high enough to be classified as type 2 diabetes. The body either doesn’t produce enough insulin or doesn’t use insulin properly, causing glucose to build up in the bloodstream. People with this condition often show no obvious symptoms, making it difficult to detect without blood tests. Over time, prediabetes can progress to type 2 diabetes if no changes are made to lifestyle or if no medical intervention occurs. The condition also increases the risk of developing heart disease and other health complications. Many people with prediabetes are unaware they have it until routine blood work reveals elevated blood sugar levels.

Trial ID:

2025-522970-35-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of dapagliflozin and semaglutide to reverse prediabetes to normal blood sugar levels in patients with coronary artery disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?