In a new research project in Denmark, more than 7,000 people with type 2 diabetes will be CT-scanned for early signs of coronary artery disease. The goals are to improve risk stratification and to achieve more individualised prevention and treatment of the people with cardiovascular disease. The project is receiving a grant of DKK 25 million from the Novo Nordisk Foundation and a grant of DKK 5 million from the Danish Heart Foundation. AstraZeneca and Novo Nordisk A/S will provide diabetes medicine for the project free of charge.
People who have type 2 diabetes also have cardiovascular disease. This has been the mantra since researchers in the 1990s focused on the close association between the two diseases. This focus has reduced the risk of cardiovascular disease over the past 10–15 years.
However, recent research shows that the risk of cardiovascular disease is not evenly distributed among people with type 2 diabetes. It is high for some and low for others. This can lead to undertreatment or overtreatment of individual patients.
“Unfortunately, we are not very good at predicting who is especially high risk. This may mean that we misjudge individuals’ real need for preventive treatment,” explains Per Løgstrup Poulsen, Professor and Chief Physician at Steno Diabetes Center Aarhus, Aarhus University Hospital and Aarhus University.
Diabetologists, cardiologists and general practitioners are therefore now joining forces in a new research project in Denmark to answer two questions: Can cardiac CT scanning identify the people with type 2 diabetes who have the highest or lowest risk of cardiovascular disease? And can we get better at balancing preventive treatment and avoid overtreatment and undertreatment?
“Cardiac CT scanning is a fantastic and increasingly common way of visualising calcium in the coronary arteries and thus early signs of cardiovascular disease. Using this method, we can find the hidden high-risk people who have no known cardiovascular disease but significant risk,” says Axel Diederichsen, Professor and Chief Physician, Department of Cardiology, Odense University Hospital and University of Southern Denmark.
He and Per Løgstrup Poulsen are the interdisciplinary leaders of the Steno INTEN-CT study, which expects up to 7,300 people with type 2 diabetes and no known cardiovascular disease to agree to participate in the project and undergo cardiac CT scanning from early 2023 until 2024.
The research group expects that about 40% of those CT-scanned will have signs of atherosclerosis that are severe enough that they are at high risk of developing cardiovascular disease. The trial will be randomised, with half of the patients receiving intensified preventive treatment that includes a combination of new diabetes medicine. This medicine is already approved for treating diabetes and is being provided free of charge and without restrictions by AstraZeneca and Novo Nordisk A/S. The other half will serve as a control group, and the participants will be blinded for the results of the CT scanning.
The aim is to investigate whether pharmaceutical treatment can prevent people from developing cardiovascular disease. The study will also contribute to elucidating whether people with a very low risk of cardiovascular disease can take less medication.
The Novo Nordisk Foundation and the Danish Heart Foundation are supporting the project with grants of DKK 25 million and DKK 5 million, respectively.
“Part of our mission at the Novo Nordisk Foundation is to promote research and innovation that contributes to the prevention and treatment of cardiometabolic diseases. That is why we are extremely excited to support this project, so that across medical specialties we can become better and more precise at organising the right treatment for the individual patient. We believe that the Steno INTEN-CT study can contribute to this,” says Henrik Sillesen, Medical Director, Novo Nordisk Foundation.
Gunnar Gislason, Chief Medical Science Officer, Danish Heart Foundation, says: “We are very happy to support this study, since it answers some very important questions for the many people with type 2 diabetes who have not already developed cardiovascular disease.”
About the study
The Steno INTEN-CT study is a collaboration between the five regional Steno Diabetes Centers, the hospital departments of cardiology and internal medicine and general practitioners throughout Denmark.
From January 2023, up to 15,000 people with type 2 diabetes without known cardiovascular disease will be invited to participate in the research project. The cardiac CT scanning will take place in departments of cardiology, and the drug treatment will be initiated at the local hospital departments of internal medicine and continued at general practitioners. Read more at www.inten-ct.rm.dk (in Danish)