A Study of Cardiovascular Events iN Diabetes PLUS (ASCEND PLUS)
Research type
Research Study
Full title
A Study of Cardiovascular Events iN Diabetes – PLUS (ASCEND PLUS)
IRAS ID
1004252
Contact name
David Preiss
Contact email
Sponsor organisation
University of Oxford
Eudract number
2021-003792-33
ISRCTN Number
ISRCTN76193287
Research summary
This trial is called ASCEND PLUS. It 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.\n\nOral semaglutide helps to control blood sugar levels and lower body weight, and is already approved for use in the UK as a treatment for some patients with type 2 diabetes. The study will involve 20,000 volunteers with type 2 diabetes aged at least 55 years who have not had a heart attack or stroke in the past. Potentially eligible participants will be identified by an automated electronic search of coded medical records held by NHS Digital (England). The trial will commence in England and the study team will subsequently seek the relevant permissions to also run the trial in Wales and Scotland.\n\nEach participant will be asked to take one study tablet each day for about 5 years and to complete a total of about 12 questionnaires during this time.\n\nHalf of the study participants will get tablets containing semaglutide and half will get inactive placebo tablets (which look like the oral semaglutide but have no active drug in them). Which treatment a participant gets is decided by chance and the participant will not know if they are taking the active tablet. No clinic visits are required as part of this study. The study medication will be sent to each participant’s address by post.\n\nThe main (primary) outcome is an expanded composite of major adverse cardiovascular events (i.e. death from heart or vascular disease, non-fatal heart attack, non-fatal stroke, transient ischaemic attack (“mini-stroke“), and heart artery balloon and stenting procedures).
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0116
Date of REC Opinion
20 May 2022
REC opinion
Further Information Favourable Opinion