4473: CV study of semaglutide in patients with type 2 diabetes
Research type
Research Study
Full title
Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes (SOUL)
IRAS ID
261604
Contact name
Stephen Bain
Contact email
Sponsor organisation
Novo Nordisk Ltd
Eudract number
2018-003141-42
Clinicaltrials.gov Identifier
U1111-1218-5368, Universal Trial Number
Duration of Study in the UK
4 years, 5 months, 8 days
Research summary
Research Summary:
The SOUL study is a randomised, double-blind, placebo-controlled trial to evaluate whether there is a cardiovascular (CV) risk reduction for oral semaglutide versus placebo in patients with type 2 diabetes (T2D) at high risk for CV disease.The trial is event driven with trial closure being performed when the targeted number of primary endpoint events has been reached.
Initially there is a screening visit and then if eligible, patients will attend a randomisation visit up to 3 weeks later and at this point they will start taking trial product. The treatment phase is expected to be 42-60 months including a follow up visit 5 weeks after end of treatment.
Eligible patients will be randomised 1:1 to receive either semaglutide or placebo and both are to be administered orally once daily and added to standard of care.
The study will involve around 9642 patients with type 2 diabetes worldwide. It is expected that about 460 of these patients will be from the UK. The trial will require participants to visit their study site 25 times and have a study visit over the telephone on 1 occasion.Lay summary of study results:
Over a mean follow-up of 47.5±10.9 months, the risk of the primary outcome in the overall trial population was 14% lower for oral semaglutide versus placebo (hazard ratio, 0.86; 95% CI, 0.77-0.96). In those taking SGLT2i at baseline, there were 143 of 1296 (semaglutide) versus 158 of 1300 (placebo) primary outcome events (hazard ratio, 0.89; 95% CI, 0.71-1.11); and 436 of 3529 versus 510 of 3525, respectively, in participants not taking SGLT2i at baseline (hazard ratio, 0.84; 95% CI, 0.74-0.95; P-interaction, 0.66). An analysis of major adverse cardiovascular events by any in-trial SGLT2i use versus no use also showed no evidence of heterogeneity in the effects of oral semaglutide. The adverse event profiles of oral semaglutide with or without concomitant SGLT2i were similar.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0515
Date of REC Opinion
31 May 2019
REC opinion
Further Information Favourable Opinion