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Active Not Recruiting NCT05441267

A Study of Cardiovascular Events iN Diabetes Plus

Conditions: Diabetes Mellitus, Type 2

Sex: All
Ages: 55 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 21296
Sponsor: University of Oxford

Location: Clinical Trial Service Unit and Epidemiological Studies Unit Oxford

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05441267). StuddyBuddy aggregates publicly available trial information.