Status:
RECRUITING
A Study of Cardiovascular Events iN Diabetes Plus
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief 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 attac...
Detailed Description
ASCEND PLUS aims to assess the effects of the GLP1 receptor agonist, oral semaglutide, on major adverse cardiovascular events in people with type 2 diabetes who have not previously suffered a heart at...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 17 2048
Estimated Enrollment :
20000 Patients enrolled
Trial Details
Trial ID
NCT05441267
Start Date
March 13 2023
End Date
August 17 2048
Last Update
May 8 2024
Active Locations (1)
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1
Clinical Trial Service Unit and Epidemiological Studies Unit
Oxford, United Kingdom