RecruitingPhase 4NCT05441267

A Study of Cardiovascular Events iN Diabetes Plus

Sponsor

University of Oxford

Enrollment

20,000 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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

Min Age: 55 Years

Inclusion Criteria2

Adults aged at least 55 years at the time of the Screening assessment
Type 2 Diabetes Mellitus (based on self-reported medical history)

Exclusion Criteria19

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

Interventions

DRUGSemaglutide Oral Tablet

Oral semaglutide 14mg daily (option to reduce to 7mg daily)

DRUGPlacebo oral tablet

Placebo oral semaglutide

Locations(1)

Clinical Trial Service Unit and Epidemiological Studies Unit

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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Visit

NCT05441267

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