Novo Nordisk’s diabetes pill clears cardiac safety hurdle

Novo Nordisk is set to file its daily semaglutide type 2 diabetes pill after it cleared a phase 3 trial assessing its cardiac safety, with results showing it also reduced the risk of cardiovascular and all-cause death in high-risk patients. The active ingredient in the tablet is the same as in its already-approved Ozempic (semaglutide) weekly GLP-1 class drug, which is vying for market share with Eli Lilly’s Trulicity (dulaglutide). But Novo aims to put further pressure on Lilly with this daily pill formulation, which will likely appeal to patients who wish to minimize the number of injections needed to control their blood sugar.
In this so-called non-inferiority trial, Novo had to show that the oral pill did not increase the risk of adverse cardiovascular events compared with placebo, an FDA-mandated test for all diabetes drugs. The double-blinded trial compared cardiovascular safety of oral semaglutide 14 mg compared with placebo, both in addition to standard of care, in 3,183 adults with type 2 diabetes at high risk of cardiovascular events.