Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
20000 participants
INTERVENTIONAL
2023-03-13
2048-08-17
Brief Summary
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Detailed Description
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Study treatment will be mailed to participants. Information regarding serious adverse events and study outcomes relevant to patients with type 2 diabetes mellitus will be collected by regular linkage to UK National Health Service health records both during the scheduled treatment period and for the subsequent 20 years' long term follow-up after the scheduled treatment period.
The trial design includes an active run-in phase, prior to randomisation, during which participants will be asked to take 4-weeks of active 3mg oral semaglutide followed by 4 to 8-weeks of active 7mg oral semaglutide daily.
Participants who are randomised will be allocated to receive either 14mg oral semaglutide or matching placebo daily during the scheduled treatment period. There will be the opportunity to reduce the dose to 7mg or matching placebo if required.
The scheduled treatment period, during which participants are requested to take the study treatment and complete follow-up assessments, is anticipated to continue until the required number of participants has experienced a primary outcome following randomisation. This is expected to occur at a median of approximately 5 years after randomisation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Oral semaglutide
14mg daily (option to reduce to 7mg daily)
Semaglutide Oral Tablet
Oral semaglutide 14mg daily (option to reduce to 7mg daily)
Placebo
Placebo oral tablet
Placebo oral semaglutide
Interventions
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Semaglutide Oral Tablet
Oral semaglutide 14mg daily (option to reduce to 7mg daily)
Placebo oral tablet
Placebo oral semaglutide
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes Mellitus (based on self-reported medical history)
Exclusion Criteria
* 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
55 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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David Preiss
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Marion Mafham
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Clinical Trial Service Unit and Epidemiological Studies Unit
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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David Preiss
Role: primary
Other Identifiers
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CTSU_ASCEND-PLUS
Identifier Type: -
Identifier Source: org_study_id
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