With regard to clinical outcomes, findings from the SUSTAIN-6 trial not only establish noninferiority to placebo, they also suggest benefit.
To fulfill an FDA requirement that new diabetes therapies demonstrate cardiovascular safety, investigators conducted an industry-sponsored, noninferiority trial of semaglutide, a glucagon-like peptide 1 analogue, for cardiovascular outcomes. They randomized 3297 patients aged 50 or older with type 2 diabetes to receive semaglutide (0.5 mg/week or 1.0 mg/week) or placebo for 104 weeks. All participants had either established cardiovascular disease or additional cardiovascular risk factors.
In the semaglutide group, the reduction in mean glycated hemoglobin was 1.1% and 1.4% at the lower and higher doses, compared with 0.4% in the placebo group. Mean weight loss in the semaglutide group was 3.6 kg and 4.9 kg, respectively, compared with about …
Reviewing Author
DisclosuresConsultant/Advisory BoardUnited Healthcare; Element Science; Eyedentifeye, F-Prime
EquityHugo Health; Refactor Health; Element Science
Grant/Research SupportPfizer; Agency for Healthcare Research and Quality; Janssen Research and Development, National Institute of Biomedical Imaging and Engineering; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; National Cancer Institute; American Heart Association
DisclosuresConsultant/Advisory BoardUnited Healthcare; Element Science; Eyedentifeye, F-Prime
EquityHugo Health; Refactor Health; Element Science
Grant/Research SupportPfizer; Agency for Healthcare Research and Quality; Janssen Research and Development, National Institute of Biomedical Imaging and Engineering; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; National Cancer Institute; American Heart Association