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Randomised controlled trial
Semaglutide is non-inferior to placebo for cardiovascular outcomes in patients with type 2 diabetes
  1. Denise Campbell-Scherer
  1. Department of Family Medicine and Alberta Diabetes Institute, University of Alberta, Edmonton, Alberta, Canada
  1. Correspondence to: Dr Denise Campbell-Scherer, Alberta Diabetes Institute, Clinical Research Unit, 2-004 Li Ka Shing Ctr, 87 Ave and 112st, Edmonton, Alberta T6G 2E1, Canada; denise.campbell-scherer{at}ualberta.ca

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Context

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

Methods

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 …

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