A Study of Cardiovascular Events iN Diabetes Plus
- Status
- Active not recruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 55 Years to no upper limit; no BMI minimum stated; conditions: Diabetes Mellitus, Type 2
- Interventions
- Semaglutide Oral Tablet; Placebo oral tablet
- Conditions
- Diabetes Mellitus, Type 2
- Phase and size
- Phase 4 · 21296 participants
- Dates
- Start 2023-03-13
Primary completion 2028-08-17 - Sponsor
- University of Oxford (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE+)Scheduled treatment period (anticipated median follow-up period of 5-years)
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.