A Study of Cardiovascular Events iN Diabetes Plus

• Status: Not yet recruiting
• Trial end date: 2048-08-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Novo Nordisk A/S

Criteria

Participants are eligible for the study if:

The inclusion criteria are satisfied; None of the exclusion criteria applies; They are willing and able to provide informed consent.

INCLUSION CRITERIA:

All of the following must be satisfied:

(i) Adults aged at least 55 years at the time of the Screening assessment

(ii) Type 2 Diabetes Mellitus (based on self-reported medical history)

EXCLUSION CRITERIA:

None of the following must apply (based on self-reported medical history):

(i) Myocardial Infarction

(ii) Stroke

(iii) Current or planned treatment with a GLP-1 RA

(iv) Previous hypersensitivity to or intolerance of GLP-1 RA therapy

(v) Severe hypoglycaemia within the last six months or during run-in

(vi) Symptomatic hypoglycaemia within the last month

(vii) Currently under consideration to commence insulin

(viii) Severe heart failure (NYHA class 4)

(ix) Current or planned renal replacement therapy

(x) Unwilling to complete regular follow-up assessments

(xi) Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years

(xii) Type 1 or other type of diabetes (e.g. MODY)

(xiii) History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

(xiv) Currently breastfeeding or pregnant, or planning a pregnancy

(xv) Any serious illness which is likely to limit survival or active participation for at least 5 years

(xvi) Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes

(xvii) 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

(xviii) Non-adherence to run-in treatment (i.e. reports taking the run-in tablets 'Never' or 'Only occasionally')

(xix) Their doctor does not wish them to be randomised.