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Cardiovascular disease is the leading cause of death and complications in patients with type 2 diabetes.1 Recently, trials evaluating a sodium-glucose cotransporter 2 inhibitor (empagliflozin) and a glucagon-like peptide 1 (GLP-1) analogue (liraglutide) have shown improved cardiovascular outcomes in patients with type 2 diabetes who were at high risk for cardiovascular events.2,3
Semaglutide, a GLP-1 analogue with an extended half-life of approximately 1 week (which permits once-weekly subcutaneous administration),4 is currently in development but not yet approved for the treatment of type 2 diabetes. Regulatory guidance specifies the need to establish the cardiovascular safety of new therapies for type 2 diabetes in order to rule out excess cardiovascular risk.5 The preapproval Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects with Type 2 Diabetes (SUSTAIN-6) was designed to assess the noninferiority of semaglutide as compared with placebo in terms of cardiovascular safety in patients with type 2 diabetes.

Trial Design and Oversight

We performed a randomized, double-blind, placebo-controlled, parallel-group trial at 230 sites in 20 countries. The trial protocol, available with the full text of this article at NEJM.org, was approved by the institutional review board and ethics committee at each participating center. All patients provided written informed consent.
Patients were randomized in a 1:1:1:1 ratio to receive either 0.5 mg or 1.0 mg of once-weekly subcutaneous semaglutide or volume-matched placebo, which maintained blinding within dose. The trial consisted of a planned observation period of 109 weeks for all patients (a 104-week treatment period with a 5-week follow-up period) in which patients who had prematurely discontinued a study treatment were also included.
The sponsor, Novo Nordisk, designed the study. Data were gathered by the site investigators, and the sponsor performed site monitoring, data collection, and data analysis. An independent data and safety monitoring committee performed ongoing surveillance and had access to all the data in an unblinded fashion.
All the authors had confidential access to the final trial results and actively contributed to manuscript preparation. A working group that included the first and last authors wrote the first draft of the manuscript, which was revised and approved by all the authors, who made the decision to submit the manuscript for publication. The authors assume responsibility for the accuracy and completeness of the data and vouch for the fidelity of the trial to the protocol. Editorial support was funded by the sponsor and provided by independent medical writers under the guidance of the authors.

Patients

Patients with type 2 diabetes and a glycated hemoglobin level of 7% or more were eligible if they had not been treated with an antihyperglycemic drug or had been treated with no more than two oral antihyperglycemic agents, with or without basal or premixed insulin. Key inclusion criteria were an age of 50 years or more with established cardiovascular disease (previous cardiovascular, cerebrovascular, or peripheral vascular disease), chronic heart failure (New York Heart Association class II or III), or chronic kidney disease of stage 3 or higher or an age of 60 years or more with at least one cardiovascular risk factor (as defined in Table S1 in the Supplementary Appendix, available at NEJM.org).
Key exclusion criteria included treatment with a dipeptidyl-peptidase 4 inhibitor within 30 days before screening or with a GLP-1-receptor agonist or insulin other than basal or premixed within 90 days before screening; a history of an acute coronary or cerebrovascular event within 90 days before randomization; planned revascularization of a coronary, carotid, or peripheral artery; or long-term dialysis.

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