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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Ryonfa Lee
+44 1865 743743
ascend-plus@ndph.ox.ac.uk


Dr David Preiss
+44 1865 743743
ascend-plus@ndph.ox.ac.uk


Dr Marion Mafham
+44 1865 743743
ascend-plus@ndph.ox.ac.uk


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Be Part of Research - Trial Details - ASCEND PLUS - a research study to test whether a treatment called oral semaglutide can protect people with type 2 diabetes from heart attacks, strokes, and other health problems
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ASCEND PLUS - a research study to test whether a treatment called oral semaglutide can protect people with type 2 diabetes from heart attacks, strokes, and other health problems

Not Recruiting

Open to: All Genders

Age: Adult

Oxford

Medical Conditions

Type 2 diabetes. The most common type of diabetes - a disease that occurs when your blood glucose (also called blood sugar) is too high.

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This trial is called ASCEND PLUS. It is testing whether, for people with type 2 diabetes who have not previously had a heart attack or stroke, regularly taking a tablet called semaglutide can safely help to reduce heart attacks, strokes, mini-strokes, the need for any procedures to unblock or bypass an artery to their heart, and the chance of dying because of vascular problems.

Oral semaglutide helps to control blood sugar levels and lower body weight, and is already approved for use in the UK as a treatment for some patients with type 2 diabetes.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

13 Mar 2023 01 Sep 2024

Each participant will be asked to take one study tablet each day for about 5 years and to complete a total of about 12 questionnaires during this time.

Half of the study participants will get tablets containing semaglutide and half will get inactive placebo tablets (which look like the oral semaglutide but have no active drug in them). Which treatment a participant gets is decided by chance and the participant will not know if they are taking the active tablet. No clinic visits are required as part of this study. The study medication will be sent to each participant's address by post.


The study will involve 20,000 volunteers with type 2 diabetes aged at least 55 years who have not had a heart attack or stroke in the past.
Potentially eligible participants will be identified by an automated electronic search of coded medical records held by NHS Digital (England). The trial will commence in England and the study team will subsequently seek the relevant permissions to also run the trial in Wales and Scotland.

You can take part if:



You may not be able to take part if:


1. Myocardial Infarction 2. Stroke 3. Current or planned treatment with a GLP-1 RA 4. Previous hypersensitivity to or intolerance of GLP-1 RA therapy5. Severe hypoglycaemia within the last six months or during run-in 6. Symptomatic hypoglycaemia within the last month7. Currently under consideration to commence insulin8. Severe heart failure (NYHA class 4) 9. Current or planned renal replacement therapy 10. Unwilling to complete regular follow-up assessments 11. Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years 12. Type 1 or other type of diabetes (e.g. MODY) 13. History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma14. Currently breastfeeding or pregnant, or planning a pregnancy15. Any serious illness which is likely to limit survival or active participation for at least 5 years 16. Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes17. For participants taking thyroxine, lack of agreement to arrange a thyroid function test in the next 3 months and agree to regular testing throughout the trial18. Non-adherence to run-in treatment (i.e. reports taking the run-in tablets ‘Never’ or ‘Only occasionally’ 19. Their doctor does not wish them to be randomised


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • ASCEND PLUS Coordinating Office
    Richard Doll Building Old Road Campus Roosevelt Drive
    Oxford
    OX3 7LF

The health of participants may or may not improve as a result of taking part in the trial. If the trial shows benefit, this will help to prevent many patients with type 2 diabetes from suffering heart attacks, strokes and other vascular problems in the future.
Oral semaglutide is approved in the UK for treating type 2 diabetes. Most people treated with oral semaglutide do not have any side effects, but about one in ten people who take the tablets experience nausea (feeling sick), vomiting, or diarrhoea. If severe, these symptoms may occasionally result in dehydration. These problems usually happen soon after starting the medication (or when the dose is increased) and go away with time. Most people who develop these symptoms do manage to continue taking oral semaglutide.
Oral semaglutide may rapidly improve blood sugar levels. Good blood sugar control helps to protect against eye disease caused by diabetes in the longer term, but fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease in some patients. It is therefore important that participants attend their NHS retinal screening appointments as part of their regular diabetes care.
Women who are pregnant, planning a pregnancy or breastfeeding will be excluded from the trial because oral semaglutide is not recommended during pregnancy or breastfeeding.
Participants who take insulin or a sulphonylurea might experience hypoglycaemia (low blood sugar or ‘hypo’) when starting taking semaglutide. It is therefore important for participants who already monitor blood sugar levels at home to continue to do this regularly.

Dr Marion Mafham
+44 1865 743743
ascend-plus@ndph.ox.ac.uk


Dr David Preiss
+44 1865 743743
ascend-plus@ndph.ox.ac.uk


Dr Ryonfa Lee
+44 1865 743743
ascend-plus@ndph.ox.ac.uk



The study is sponsored by University of Oxford and funded by Novo Nordisk.




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What will you do next?
Read full details for Trial ID: ISRCTN76193287

Or CPMS 51088

Last updated 16 March 2023

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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