Trial shows cardiovascular safety with Novo Nordisk’s diabetes drug

12th June 2019 (Last Updated August 9th, 2019 09:28)

Novo Nordisk has reported that its oral semaglutide medicine showed non-inferiority compared to placebo in major adverse cardiovascular events (MACE) during the PIONEER 6 clinical trial in type 2 diabetes patients.

Trial shows cardiovascular safety with Novo Nordisk’s diabetes drug
Oral semaglutide is an investigational glucagon-like peptide-1 (GLP-1) analogue formulated as a pill. Credit: Novo Nordisk A/S.

Novo Nordisk has reported that its oral semaglutide medicine showed non-inferiority compared to placebo in major adverse cardiovascular events (MACE) during the PIONEER 6 clinical trial in type 2 diabetes patients.

The trial’s primary endpoint was the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

PIONEER 6 met the endpoint with a hazard ratio of 0.79 in favour of semaglutide compared to placebo.

The data is an aggregation of 137 first major adverse cardiovascular events and a median follow-up of 16 months.

Oral semaglutide is an investigational glucagon-like peptide-1 (GLP-1) analogue formulated as a pill.

The randomised, double-blinded, placebo-controlled, event-driven, pre-approval cardiovascular outcomes trial compared the cardiovascular safety of the therapeutic to placebo when added to standard of care. It recruited a total of 3,183 patients at high risk of cardiovascular events.

According to the findings, the MACE was driven by its individual components.

Cardiovascular death events were 15 with oral semaglutide compared to 30 with placebo, while non-fatal stroke events were 12 versus 16.

However, the number of non-fatal myocardial infarctions with the therapeutic was not significantly different to placebo, with the numbers being recorded at 37 and 31, respectively.

In addition, the oral semaglutide group showed significantly lower all-cause deaths compared to patients on placebo.

During the trial, the safety profile of Novo Nordisk’s drug was consistent with that of the GLP-1 receptor agonist class and similar to subcutaneous semaglutide.

Novo Nordisk executive vice-president and chief science officer Mads Krogsgaard Thomsen said: “The results of PIONEER 6 further strengthen the overall clinical evidence for oral semaglutide, building upon the strong clinical data reported throughout the PIONEER clinical trial programme.

“We are excited about the potential of oral semaglutide to become the first and only oral GLP-1 treatment for people with type 2 diabetes.”

The PIONEER clinical development programme involved 9,543 type 2 diabetes patients in ten trials.