Actively Recruiting
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
Eligibility Criteria
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)
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
Trial Site Locations
Total: 1 location
1
Clinical Trial Service Unit and Epidemiological Studies Unit
Oxford, United Kingdom
Actively Recruiting
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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