Novo Nordisk has reported positive results from the SUSTAIN 6 trial, a Phase llla trial of Ozempic (semaglutide) for the treatment of patients with type 2 diabetes.
SUSTAIN 6 is part of the global SUSTAIN clinical development programme for Ozempic, which features eight Phase llla trials.
The SUSTAIN programme has enrolled more than 8,000 adults with type 2 diabetes, including some patients with high-cardiovascular risk profiles.
The SUSTAIN 6 trial enrolled 3,297 people with type 2 diabetes and established cardiovascular disease or with at least one cardiovascular risk factor.
It was conducted to analyse the non-inferiority of Ozempic in comparison with placebo, when administered along with standard of care.
The newly presented results, which are based on two post-hoc subgroup analyses of the SUSTAIN 6 trial, have showed Ozempic’s consistency in lowering the risk of major adverse cardiovascular events (MACE) in the patients who are at high-cardiovascular risk irrespective of their profile at the beginning of the trial.
The results showed that Ozempic-treated patients witnessed a 26% less risk of MACE versus those receiving placebo over a period of two years.
Swansea University UK School of Medicine professor Stephen Bain said: “Cardiovascular disease remains the leading cause of disability and death in people with type 2 diabetes and there is an increasing focus on reducing cardiovascular risk in the clinic.
“We have seen from clinical trials that diabetes treatments confer variable effects on cardiovascular outcomes and the results of these post-hoc analyses provide further evidence of the consistent cardiovascular risk reduction of Ozempic in people with type 2 diabetes, with varying profiles of cardiovascular risk at baseline.”
Ozempic is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1) formulated for the treatment of adults with insufficiently controlled type 2 diabetes.