Testing a medication to reduce heart problems in people with type 2 diabetes
A Study of Cardiovascular Events iN Diabetes Plus
This study is testing if a new medication can help prevent heart problems in people with type 2 diabetes who haven't had a heart attack or stroke yet.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20000 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford) |
| Trial ID | NCT05441267 on ClinicalTrials.gov |
What this trial studies
ASCEND PLUS is evaluating the effects of oral semaglutide on major cardiovascular events in individuals with type 2 diabetes who have not experienced a heart attack or stroke. The study utilizes a novel approach by identifying participants through NHS healthcare datasets and conducting all interactions via web-based technology, telephone, and mail. Participants will undergo an active run-in phase before being randomized to receive either semaglutide or a placebo. The study aims to collect long-term health outcome data through linkage to NHS records over a 20-year follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55 and older with type 2 diabetes who have not had a heart attack or stroke.
Not a fit: Patients with a history of heart attack, stroke, or severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of heart attacks and strokes in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with GLP-1 receptor agonists in cardiovascular risk reduction, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Oxford
- Clinical Trial Service Unit and Epidemiological Studies Unit — Oxford, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David Preiss — University of Oxford
- Study coordinator: Ryonfa Lee
- Email: ascend-plus@ndph.ox.ac.uk
- Phone: 01865 743743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.