A Study of Cardiovascular Events iN Diabetes Plus

Summary

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.

Eligibility

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

Conditions2

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