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A Study of Cardiovascular Events iN Diabetes Plus

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: Mix of remote tasks and in-person visits
Drug or intervention: Semaglutide Oral Tablet (drug), Placebo oral tablet (drug)
How long the study runs: Study runs about 305 months (dates as stated)
About the drug or intervention: Semaglutide Oral Tablet — drug: Oral semaglutide 14mg daily (option to reduce to 7mg daily) · Placebo oral tablet — drug: Placebo oral semaglutide
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 55 Years and over
Who: All
Number of participants: 21,296
Started: 2023-03-13
Last checked: 2026-06

Plain English Summary

What is this study?

• Testing a new treatment for diabetes mellitus, type 2
• Phase4 - 21,296 participants
• ASCEND PLUS 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

Who can take part?

• Ages 55 Years and over
• Diagnosed with diabetes mellitus, type 2

Where?

• Oxford - Clinical Trial Service Unit and Epidemiological Studies Unit

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

ASCEND PLUS 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.

More detail

ASCEND PLUS aims to assess the effects of the GLP1 receptor agonist, oral semaglutide, on major adverse cardiovascular events in people with type 2 diabetes who have not previously suffered a heart attack or stroke. The study will be conducted using novel, streamlined methodology. Participants will be identified from centrally held routinely collected NHS healthcare datasets and invited to join the trial. There will be no physical sites, and all interactions with participants will be conducted directly using innovative patient-centred web-based technology, supplemented by telephone, video call contact and mailed letters. Study treatment will be mailed to participants. Information regarding serious adverse events and study outcomes relevant to patients with type 2 diabetes mellitus will be collected by regular linkage to UK National Health Service health records both during the scheduled treatment period and for the subsequent 20 years' long term follow-up after the scheduled treatment period. The trial design includes an active run-in phase, prior to randomisation, during which participants will be asked to take 4-weeks of active 3mg oral semaglutide followed by 4 to 8-weeks of active 7mg oral semaglutide daily. Participants who are randomised will be allocated to receive either 14mg oral semaglutide or matching placebo daily during the scheduled treatment period. There will be the opportunity to reduce the dose to 7mg or matching placebo if required. The scheduled treatment period, during which participants are requested to take the study treatment and complete follow-up assessments, is anticipated to continue until the required number of participants has experienced a primary outcome following randomisation. This is expected to occur at a median of approximately 5 years after randomisation.

Diabetes Mellitus, Type 2

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 55 Years and over
Who can join: All genders

What the study is looking for

✓Adults aged at least 55 years at the time of the Screening assessment
✓Type 2 Diabetes Mellitus (based on self-reported medical history)

Who cannot take part

✗Myocardial Infarction
✗Stroke
✗Current or planned treatment with a GLP-1 RA
✗Previous hypersensitivity to or intolerance of GLP-1 RA therapy
✗Severe hypoglycaemia within the last six months or during run-in

See the full criteria

Inclusion Criteria: * Adults aged at least 55 years at the time of the Screening assessment * Type 2 Diabetes Mellitus (based on self-reported medical history) Exclusion criteria: * Myocardial Infarction * Stroke * Current or planned treatment with a GLP-1 RA * Previous hypersensitivity to or intolerance of GLP-1 RA therapy * Severe hypoglycaemia within the last six months or during run-in * Symptomatic hypoglycaemia within the last month * Currently under consideration to commence insulin * Severe heart failure (NYHA class 4) * Current or planned renal replacement therapy * Unwilling to complete regular follow-up assessments * Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years * Type 1 or other type of diabetes (e.g. MODY) * History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * Currently breastfeeding or pregnant, or planning a pregnancy * Any serious illness which is likely to limit survival or active participation for at least 5 years * Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes * 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 trial * Non-adherence to run-in treatment (i.e. reports taking the run-in tablets 'Never' or 'Only occasionally') * Their doctor does not wish them to be randomised

Where Is This Study? (1 UK site)

Clinical Trial Service Unit and Epidemiological Studies Unit

Oxford, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-06