Actively Recruiting

Phase 4
Age: 55Years +
All Genders
NCT05441267

A Study of Cardiovascular Events iN Diabetes Plus

Led by University of Oxford · Updated on 2024-05-08

20000

Participants Needed

1

Research Sites

1327 weeks

Total Duration

On this page

Sponsors

U

University of Oxford

Lead Sponsor

N

Novo Nordisk A/S

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of Cardiovascular Events iN Diabetes Plus

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged at least 55 years at the time of the Screening assessment
  • Type 2 Diabetes Mellitus (based on self-reported medical history)
Not Eligible

You will not qualify if you...

  • History of myocardial infarction
  • History of stroke
  • Current or planned treatment with a GLP-1 receptor agonist
  • Previous hypersensitivity or intolerance to GLP-1 receptor agonist therapy
  • Severe hypoglycaemia within the last six months or during run-in phase
  • Symptomatic hypoglycaemia within the last month
  • Currently being considered to start insulin treatment
  • Severe heart failure (NYHA class 4)
  • Current or planned renal replacement therapy
  • Unwillingness to complete regular follow-up assessments
  • Ongoing cancer treatment or cancer diagnosis (excluding non-melanoma skin cancer) within the last 2 years
  • Type 1 diabetes or other diabetes types (e.g., MODY)
  • History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • Currently breastfeeding, pregnant, or planning pregnancy
  • Any serious illness likely to limit survival or active participation for at least 5 years
  • Current participation in another clinical trial using an unlicensed diabetes treatment
  • For those taking thyroxine, refusal to arrange thyroid function testing during the trial
  • Non-adherence to run-in treatment (taking run-in tablets rarely or never)
  • Doctor does not wish the participant to be randomized

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Clinical Trial Service Unit and Epidemiological Studies Unit

Oxford, United Kingdom

Actively Recruiting

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Research Team

R

Ryonfa Lee

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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