What is the role of semaglutide (Ozempic and Rybelsus) in the treatment of type 2 diabetes mellitus (DM)?

Updated: Oct 23, 2019
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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In December 2017, the FDA approved semaglutide (Ozempic), a GLP-1 receptor agonist, as a glycemic control–improvement agent in adults with type 2 diabetes. It is administered as a subcutaneous injection once weekly. Meant as an adjunct to diet and exercise, semaglutide was approved following eight phase 3a studies (the SUSTAIN trials). Moreover, in the SUSTAIN-6 study, the cardiovascular outcomes trial, the drug was found to contribute to cardiovascular risk reduction. [182, 183]

In September 2019, the FDA approved the first oral GLP-1 receptor agonist, semaglutide (Rybelsus). It is administered as a once daily oral tablet. Approval of the oral tablet was based on results from the phase 3 PIONEER trials (n=9543). The trials included head-to-head studies of oral semaglutide compared with sitagliptin (DP4 inhibitor), empagliflozin (SGLT2 inhibitor), and liraglutide 1.8 mg (GLP-1 agonist). A1c reduction was found with oral semaglutide, as well as, via a secondary endpoint, body weight reduction. [184, 185, 186]

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