Novo Nordisk’s oral semaglutide is one step closer to being made available for people with type 2 diabetes.
The first oral GLP-1 analogue in tablet form has been assessed for cardiac safety in a recent trial and was found to reduce the risk of adverse cardiovascular events.
Oral semaglutide works by stimulating insulin and reducing appetite in those with type 2 diabetes.
Novo’s injectable semgalutude, Ozempic, was approved for use by the European Commission earlier this year.
The latest stage in the PIONEER study (PIONEER 6) involved more than 3,000 people with type 2 diabetes who were deemed at high risk of cardiovascular events. They were split into two groups and half were given 14mg of semaglutide orally and the other half as a placebo.
The research team measured how the drug impacted major adverse cardiovascular events (MACE), such as death related to a cardiovascular condition.
The findings showed there was a 21% reduced risk of enduring a cardiovascular-related health complaint in those who took the pill. Overall there was a 49% reduction in mortality overall in favour of oral semaglutide.
There were also improvements in HbA1c, body weight and blood pressure which were similar to findings observed in previous PIONEER trials for oral semaglutide.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of the pharmaceutical company, 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.
“Based on the strong clinical data reported throughout the PIONEER clinical trial programme, we have now established a solid efficacy and safety profile for oral semaglutide and we are looking forward to sharing the results with regulatory authorities during 2019.”
