Dapagliflozin and endothelial function in type 2 diabetes
Research type
Research Study
Full title
The effects of add-on treatment with Dapagliflozin on endothelial function in participants treated with GLP-1 analogues and suboptimal glycaemic control
IRAS ID
190541
Contact name
Jemma Hughes
Contact email
Sponsor organisation
Abertawe Bro Morgannwg University LHB
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Dapagliflozin is a medication that licensed and used routinely in the treatment of type 2 diabetes to improve blood sugar control and works by stopping the re-absorption of sugar from the kidney acting through blocking a channel called "Sodium glucose co-transporter-2 (SGLT2)". This medication can be used with any other therapies used to treat high blood sugar levels in patients with type 2 diabetes. Of interest prior to insulin therapy it may be used with a group of medication called glucagon-like peptide-1 (GLP-1) analogues. Patients with diabetes are at an increased risk of circulatory disease such as coronary heart disease and there is evidence to suggest that GLP-1 analogues may have a beneficial effect on the circulation (endothelial function). This proposal will examine the effects of add-on treatment with dapagliflozin on the circulation (endothelial function) in participants routinely treated with GLP-1 analogues who have suboptimal glycaemic control. Participants will be recruited from those patients where dapagliflozin would be chosen in routine clinical practice as the next add-on medication to improve sugar control. This study will be a prospective observational on-randomised study where no placebo or cross-over will take place. We aim to recruit 30 participants who will be identified from the diabetes clinics within ABM University Health Board. Following informed consent participants will visit the clinical research unit/facilty (Morriston Hospital/Institute of Life Sciences, Swansea University) at baseline, 3 and 6 months. The three main objectives are:- (i) To examine for a change in global endothelial function associated with dapagliflozin add-on therapy. (ii) To examine for a change in peripheral vascular and biochemical markers of endothelial function associated with dapagliflozin add-on therapy. (iii) To measure change in glycaemic control associated with add-on dapagliflozin therapy. The recruitment of participants and data collection will last 12 months.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0406
Date of REC Opinion
5 Nov 2015
REC opinion
Further Information Favourable Opinion