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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 …
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