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.’
