Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial

This RCT (n=387) reports that at week 30, compared with placebo, semaglutide significantly reduced HbA1c with the 0.5mg dose (estimated treatment difference vs placebo –1.43%, p<0•0001), and with the 1.0mg dose (–1•53%, p<0•0001]). A decrease in bodyweight was similarly noted.

In a related editorial, the author comments on the developmental status of semaglutide, highlighting that studies of head-to-head comparisons are ongoing between semaglutide and empagliflozin, sitagliptin, and liraglutide. Additionally, because of the impressive results noted with body weight reduction in the SUSTAIN 1 study, an investigational programme to assess semaglutide for the treatment of obesity in patients without type 2 diabetes has been initiated.

 

Semaglutide is a subcutaneously administered once-weekly human GLP-1 (glucagon-like peptide-1) analogue.

 

Applications for marketing authorisation have been submitted to both the US Food and Drug Administration and the European Medicines Agency for once weekly semaglutide in the treatment of type 2 diabetes; the submissions are based on the results of the SUSTAIN clinical trial programme, which included 8 studies and over 8,000 subjects