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 risk of cardiovascular and all-causes 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 minimise 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 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.

The PIONEER 6 trial met its main goal, measured against the composite major adverse cardiovascular events (MACE) endpoint, comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

Results also showed a non-significant reduction in MACE, with patients taking the pill 21% less likely to suffer an event.

Novo said the MACE results were driven by a statistically significant reduction in cardiovascular death of 51%, while non-fatal myocardial infarction or non-fatal stroke were broadly similarly distributed between two treatment arms.

There was also a statistically significant reduction in all-cause mortality of 49% in favour of oral semaglutide.

The improvements in secondary endpoints including HbA1c, body weight and blood pressure were similar to results reported throughout the PIONEER programme for oral semaglutide.

The safety profile of oral semaglutide in PIONEER 6 was consistent with the established safety profile observed in previous PIONEER clinical trials.

Mads Krogsgaard Thomsen, chief science officer of Novo Nordisk, said: “We are very encouraged that PIONEER 6 demonstrated cardiovascular safety as well as a significant reduction in both CV and all-cause mortality following oral semaglutide treatment in people with type 2 diabetes at high cardiovascular risk.”

The PIONEER phase 3a clinical development programme for oral semaglutide is a series of global trials involving 8,845 people with type 2 diabetes across 10 clinical trials, which have all been completed in 2018.

 

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