Novo Nordisk has revealed positive data from a phase 3 trial investigating a higher-dose of its type 2 diabetes drug Ozempic, showing superior reductions in blood sugar compared to the standard dose.
In the late-stage SUSTAIN FORTE trial, an investigational 2 mg dose of Ozempic (semaglutide) led to statistically significant and superior reductions in blood sugar – HbA1c – compared to Ozempic 1 mg.
The results, presented at the Annual Scientific Sessions of the American Diabetes Association (ADA), showed that the trial met its primary endpoint – patients with an elevated mean baseline HbA1c of 8.9% who were treated with once-weekly Ozempic 2 mg demonstrated a 2.2% reduction in blood sugar compared with a 1.9% reduction for those receiving Ozempic 1 mg after 40 weeks.
Post-hoc subgroup analyses also demonstrated that the higher dose of Ozempic demonstrated greater reductions in blood sugar at 40 weeks compared with Ozempic 1 mg across baseline HbA1c subgroups.
In addition, Ozempic 2 mg demonstrated a statistically significant weight reduction of 6.9 kg compared with 6.0 kg for Ozempic 1 mg.
Further post-hoc analyses from across baseline BMI subgroups showed greater non-significant reductions in body weight with Ozempic 2 mg compared with the 1 mg dose.
On top of that, the incidence of adverse events were similar for both dose groups in the primary analysis, with the most common being gastrointestinal events such as nausea, diarrhoea and vomiting.
“Ozempic has helped millions of people with type 2 diabetes worldwide lower their blood sugar, reduce their risk of major cardiovascular events in adults with established cardiovascular disease and has demonstrated weight reduction for some patients,” said Martin Lange, executive vice president of Novo Nordisk.
“[This data shows] us that with a higher 2.0 mg dose of Ozempic, we can help even more adults living with type 2 diabetes, who are not at glycaemic control, lower their HbA1c,” he added.
Novo Nordisk has already submitted a label extension applications to the European Medicines Agency (EMA) based on the primary results from this study, as well as to the US Food and Drug Administration (FDA), to evaluate the Ozempic 2 mg dose for adults with type 2 diabetes.
The company may face new competition in the type 2 diabetes area soon, as a regulatory filing for Eli Lilly’s investigational GIP and GLP-1 receptor agonist tirzepatide looms.
Also at ADA, Lilly revealed that all doses of tirzepatide tested in a phase 3 trial – 5 mg, 10 mg or 15 mg – led to significant and superior HbA1c and body weight reductions for type 2 diabetes patients compared to Ozempic 1 mg.