Madurasinghe, Vichithranie W.
Mafham, Marion
Buck, Georgina
Bowman, Louise
Armitage, Jane
Funding for this research was provided by:
British Heart Foundation (University of Oxford received a Special Project Grant from 2003 to 2008 (SP/03/002))
British Heart Foundation (followed by two renewals of the grant in 2009-2013 (SP/08/010/259))
British Heart Foundation (2015-2019 (SP/14/3/31114))
Bayer and Solvay Pharmaceuticals (the Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) at the University of Oxford received study drug)
Bayer and Solvay Pharmaceuticals (funding for drug packaging)
Medical Research Council (the Clinical Trial Service Unit)
Medical Research Council (Epidemiological Studies Unit (CTSU) received funding the UK Medical Research Council)
Cancer Research UK (Some study staff at the Clinical Trial Service Unit)
Cancer Research UK (Epidemiological Studies Unit (CTSU) at the University of Oxford supported by this funder.)
Health Data Research UK (the Clinical Trial Service Unit)
Health Data Research UK (Epidemiological Studies Unit (CTSU) at the University of Oxford is the recipient)
Article History
Received: 23 April 2025
Accepted: 5 February 2026
First Online: 27 February 2026
Declarations
:
: Multi-centre Research Ethics Committee (MREC) approval was obtained in 2003 (North West REC, ref 03/8/087) for the study protocol and, in particular, to use centrally held diabetes registers to identify potential participants. Regulatory approval was obtained from the Medicines and Healthcare Products Regulatory Agency (MHRA), and permission to obtain identifiable details of people with diabetes without their explicit consent (in order to invite them to participate in the trial) was obtained from the Patient Information Advisory Group (PIAG), constituted under Sect. 60 of the NHS Act 2001 (subsequently the National Information Governance Board under Sect. 251 of the National Health Service Act 2006, and more recently the Confidentiality Advisory Group). The coordinating centre ensured that the necessary Research Governance approvals were also in place for the invitations to be sent from general practices. All participants took part in ASCEND provided written informed consent. This work uses data provided by patients and collected by the NHS as part of their care and support. Linked healthcare data on admissions to hospital were provided by NHS England, the Secure Anonymised Information Linkage (SAIL) at University of Swansea and Public Health Scotland.
: This manuscript does not contain any individual person’s data in any form.
: The authors declare that they have no competing interests.