Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Eligible participants will initially enter an active run-in phase during which they will be asked to take one tablet daily of oral semaglutide 3mg for 4 weeks, followed by oral semaglutide 7mg for 4-8
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
55 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged at least 55 years 2. Type 2 diabetes mellitus
Exclusion criteria
Exclusion criteria: 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 therapy 5. Severe hypoglycaemia within the last six months or during run-in 6. Symptomatic hypoglycaemia within the last month 7. Currently under consideration to commence insulin 8. 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 carcinoma 14. Currently breastfeeding or pregnant, or planning a pregnancy 15. 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 diabetes 17. 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 18. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of the expanded composite of major adverse cardiovascular events (MACE+), defined as: 1. Death from cardiovascular disease 2. Non-fatal myocardial infarction 3. Non-fatal stroke 4. Transient ischaemic attack 5. Coronary revascularisation Follow-up of all randomised participants is scheduled to continue until the required number of participants has experienced a primary outcome following randomization. This is expected to occur when average follow up duration is approximately 5 years. Pre-specified outcomes and serious adverse events will be identified by regular linkage to NHS records, supplemented by seeking information from participants for certain events during follow-up assessments (conducted at six-monthly intervals). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of the composite of major cardiovascular events (MACE), defined as: 1. Death from cardiovascular disease 2. Non-fatal myocardial infarction 3. Non-fatal stroke Follow-up of all randomised participants is scheduled to continue until the required number of participants has experienced a primary outcome following randomization. This is expected to occur when average follow up duration is approximately 5 years. Pre-specified outcomes and serious adverse events will be identified by regular linkage to NHS records, supplemented by seeking information from participants for certain events during follow-up assessments (conducted at six-monthly intervals). | — |
Countries
England, United Kingdom
Contacts
Public ContactRyonfa Lee
Outcome results
None listed