Semaglutide is non-inferior to placebo for cardiovascular outcomes in patients with type 2 diabetes.

Abstract

Commentary on: Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. NEJM 2016;375:1834–44.[OpenUrl][1] Semaglutide is a glucagon-like peptide 1 (GLP-1) analogue under development for the treatment of type 2 diabetes. It is molecularly related to liraglutide but has a longer half-life, requiring once weekly dosing. US Food and Drug Administration (FDA) regulatory guidance requires evidence that new therapies for type 2 diabetes are not associated with an unacceptable increase in cardiovascular risk.1 ,2 This is defined as evidence that compared with placebo the risk ratio estimate has an upper 95% CI of 1.3; the initial preapproval phase may target the 1.8 margin; however, if 1.3 is not achieved then a postmarketing randomised safety trial is required.1 ,2 This was an industry-sponsored, non-inferiority randomised controlled trial in 3297 patients from 230 sites randomised (1:1:1:1), stratified (cardiovascular disease status, insulin treatment, and glomerular filtration rate at screening), to receive semaglutide (either 0.5 or 1.0 mg subcutaneously, weekly) or placebo. In … [1]: {openurl}?query=rft.jtitle%253DNEJM%26rft.volume%253D375%26rft.spage%253D1834%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx