A new study led by the Nuffield Department of Population Health at the University of Oxford will research whether a daily tablet could help protect the millions of people worldwide with type 2 diabetes from developing cardiovascular disease.
Cardiovascular disease is the leading global killer, causing approximately 18 million deaths worldwide each year. Even when non-fatal, cardiovascular events (such as heart attacks and strokes) often result in reduced quality of life and disability. People with diabetes are especially vulnerable, since this condition roughly doubles the risk of developing cardiovascular disease. Given that approximately one in eleven adults worldwide has diabetes (with around 90% having type two diabetes), there is an urgent need for effective treatments that can protect this at-risk group.
To date, most studies have focused on stopping the recurrence of cardiovascular events in those who already have type 2 diabetes and cardiovascular disease (secondary prevention) or are at high risk of developing cardiovascular disease because of other conditions.
A major new investigator-initiated study, coordinated by the Nuffield Department of Population Health at the University of Oxford and funded by the Danish healthcare company, Novo Nordisk, will test whether taking a daily tablet that contains semaglutide can protect people with type 2 diabetes from suffering heart attacks, strokes and other cardiovascular events. The study, ASCEND PLUS, is the latest in the ASCEND (A Study of Cardiovascular Events iN Diabetes) series of clinical trials and aims to recruit 20,000 UK adults, aged 55 years and older, who have diabetes but have not suffered a heart attack or stroke in the past.
Dr Marion Mafham, co-lead investigator for the study, said ‘Previous trials suggest that semaglutide, and similar drugs, reduce the risk of heart attacks, strokes and other cardiovascular events in people with type 2 diabetes. However, these trials studied people who already had cardiovascular disease or were at high risk of developing it.
‘The exact mechanism for these protective effects is not fully understood, but semaglutide has been shown to lower blood pressure, reduce weight and lead to improved control of blood sugar. This means that taking semaglutide could also bring various long-term benefits, particularly in reducing complications caused by obesity, other health problems such as liver and kidney disease, and potentially dementia. However, we need to test the treatment in a large-scale study to find out whether it will help a wide range of people with type 2 diabetes.’
The study will draw on the Department’s established expertise in leading large, streamlined, ground-breaking trials. Rather than seeing participants in person, the treatment with oral semaglutide or a placebo will be sent to them by post. Information on side effects will be collected remotely every six months, using online questionnaires, telephone surveys and video chats.
Associate Professor David Preiss, co-lead investigator, said ‘We know that needing to travel to trial sites can be a barrier to participating in clinical trials for some people. Using postal, phone and online services will allow people from across the UK to participate. It will enable us to include those living in remote areas and those who would find travel difficult, whilst making sure that participants have a variety of ways to keep in touch with us.’
People with type 2 diabetes who may be eligible for the study will be sent an invitation letter and information leaflet and will be asked to contact the coordinating centre if they are interested in taking part. The trial will begin enrolling participants in 2022. Participants will be asked to take the treatment with oral semaglutide or placebo for about five years.
Dr Elizabeth Robertson, Director of Research at Diabetes UK, said ‘Cardiovascular disease is a serious complication of diabetes, and with over 590 heart attacks and over 770 strokes related to diabetes each week in the UK, it’s crucial we find new ways to help people reduce their risk of these complications.’
‘Lifestyle changes such as eating healthily, stopping smoking, and keeping active can help people with type 2 diabetes to reduce their risk of complications, but these can be difficult to achieve and what works for some people may not work for others. We hope this large-scale trial will uncover whether taking semaglutide could help reduce the risk of heart complications in a wide range of people living with type 2 diabetes, helping more people to live well with the condition.’