RecruitingPHASE4INTERVENTIONAL

A Study of Cardiovascular Events iN Diabetes Plus

The ASCEND PLUS study is looking into whether a daily tablet called semaglutide can help people with type 2 diabetes reduce their risk of serious heart problems, like heart attacks or strokes. This particular study is for those who haven't had these issues before. Researchers also want to see if it can prevent mini-strokes, the need for heart artery procedures, and death from heart-related conditions. The study is run entirely from people's homes across the UK, meaning no hospital visits. Participants will receive medication by post and have contact with the study team via phone or online. The study will last for about 5 years, with long-term health information collected for 20 years afterwards from NHS records.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of Oxford

Enrolment target

20,000

Start

13 Mar 2023

Estimated completion

17 Aug 2048

Diabetes Mellitus, Type 2

What is this study about?

The ASCEND PLUS study wants to find out if a daily tablet called semaglutide can help protect the hearts of people with type 2 diabetes. Specifically, it's for those who have not previously experienced a heart attack or stroke. Researchers are keen to see if taking this medication can reduce the chances of having a heart attack, stroke, or mini-stroke. They also want to know if it can lower the need for heart operations, such as those to clear blocked arteries, and ultimately, reduce the risk of dying due to heart and blood vessel problems.

What's really ground-breaking about this study is how it's being run. Instead of going to a clinic, everything happens from your home. The study team will get in touch with potential participants using information from NHS health records. If you decide to take part, all your interactions will be online, by phone, or through letters. This means you won't have to travel for appointments, making it easier to join and stay involved, no matter where you live in the UK.

This type of research is really important because it helps us understand new ways to improve the health of people with type 2 diabetes and prevent serious heart-related complications. By studying semaglutide in this way, scientists hope to gather valuable information that could help many others in the future.

Key takeaways

Study examines if semaglutide reduces heart/stroke risks in type 2 diabetes.
For those who haven't had a heart attack or stroke before.
Study is entirely home-based – no clinic visits.
Participation lasts about 5 years for treatment, with 20 years of follow-up.
You might take active semaglutide or an inactive placebo.
Aims to find new ways to protect hearts in diabetes.

Who may be eligible?

To be considered for this study, you must be an adult aged 55 or older and have type 2 diabetes. The study relies on you telling us about your medical history regarding your diabetes and any past health issues.

There are some reasons why you might not be able to join. For instance, if you've already had a heart attack or a stroke, this study isn't suitable for you. Also, if you're already taking or planning to take a similar type of diabetes medication called a GLP-1 RA, or if you've had a bad reaction to one in the past, you wouldn't be able to participate.

Other reasons to exclude someone include severe heart failure, kidney dialysis, certain types of cancer treatment, or if you've recently had very severe or frequent low blood sugar (hypoglycaemia). If you are pregnant, planning to become pregnant, or breastfeeding, you also won't be able to join. We also need to be sure you are well enough to participate for the full study period, which could be around 5 years.

Quick self-check

Are you 55 years old or older?
Do you have type 2 diabetes?
Have you *never* had a heart attack or stroke?
Are you *not* currently pregnant, breastfeeding, or planning a pregnancy?
Are you *not* currently taking similar diabetes medication called a GLP-1 RA?
Are you well enough to participate for the next 5 years?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, it will be split into a few parts. First, there's an 'active run-in' period. For about 4 weeks, you'll take a low dose of the semaglutide tablet daily, followed by a slightly higher dose for another 4 to 8 weeks. This helps to see how you get on with the medication.

After the run-in, you'll be randomly assigned to one of two groups for the main part of the study: one group will take the 14mg semaglutide tablet daily, and the other will take a 'placebo' tablet. A placebo looks exactly like the study drug but doesn't contain any active medicine. Neither you nor the study team will know which tablet you're taking. You might be able to reduce your dose to 7mg if needed.

All your medication will be sent directly to your home. We'll keep in touch with you using online tools, phone calls, and letters. There are no clinic visits required. The main part of the study where you take the medication and have check-ins is expected to last for about 5 years. After that, we'll continue to track your health through your NHS records for a much longer period, up to 20 years, to see the very long-term effects.

Potential risks and benefits

Taking part in this study could offer several potential benefits. For healthy volunteers, it contributes to medical research and could lead to new treatments. For patients, you might receive a medication that could lower your risk of serious heart and stroke problems, or you might receive a placebo which is inactive – in either case, you will be closely monitored. However, like all medications, semaglutide can have side effects, such as tummy upset, and we will monitor for these and other more serious events. Low blood sugar is also a possible side effect for people with diabetes. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Clinical Trial Service Unit and Epidemiological Studies Unit
Oxford, United Kingdom· Recruiting

Common questions

What is a 'placebo' tablet?

A placebo tablet looks exactly like the study medication but does not contain any active medicine. It's used to compare the real drug's effects.

Do I have to go to a clinic for this study?

No, this study is entirely home-based. All interactions, including receiving medication and communication with the study team, will be done remotely.

How long will I be in the study?

The main treatment period is expected to last about 5 years, during which you'll take the study medication. Your health will then be followed for up to 20 years using your NHS records.

Will I know if I'm taking the real drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are taking semaglutide or the placebo until the study is over.

What if I decide I don't want to continue?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Ryonfa Lee

ascend-plus@ndph.ox.ac.uk 01865 743743 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.