The company has presented data showing that an investigational 2.0 mg dose of Ozempic provided statistically significant and superior reductions in blood sugar compared with Ozempic 1.0 mg.
These data were the outcome of the SUSTAIN FORTE trial, a phase 3b, 40-week, efficacy and safety trial comparing once-weekly semaglutide 2.0 mg vs Ozempic 1.0 mg as add-on to metformin with or without sulfonylureas in 961 adults with type 2 diabetes in need of additional blood sugar reduction, states the company in a press release.
”Some people living with type 2 diabetes require additional support to reach their blood glucose targets,” says Juan Pablo Frias, medical director of the National Research Institute, Los Angeles, and principal investigator of SUSTAIN FORTE. “The reductions in blood glucose seen with semaglutide 2.0 mg demonstrate that a higher dose of Ozempic may offer individuals the opportunity to further improve their diabetes control, with comparable tolerability to Ozempic 1.0 mg.”
The SUSTAIN FORTE trial
The trial met its primary endpoint, where people treated with once-weekly semaglutide 2.0 mg with an elevated mean baseline HbA1C of 8.9% demonstrated a statistically significant and superior 2.2% reduction in HbA1C compared with a reduction of 1.9% seen with Ozempic 1.0 mg after 40 weeks, when taken as intended. Further post-hoc subgroup analyses, presented at the congress, showed that semaglutide 2.0 mg demonstrated greater reductions in blood sugar at 40 weeks compared with Ozempic 1.0 mg, across baseline HbA1C subgroups.
From a mean baseline body weight of 99.3 kg, semaglutide 2.0 mg demonstrated a statistically significant weight reduction of 6.9 kg compared with 6.0 kg with Ozempic 1.0 kg. Further post-hoc analyses presented across baseline BMI subgroups showed greater non-significant reductions in body weight with semaglutide 2.0 mg compared with the 1.0 mg dose. The incidence of adverse events (AEs) was similar for both doses in the primary analysis and included gastrointestinal events (nausea, diarrhoea and vomiting) across baseline HbA1C and BMI subgroups. This is consistent with AEs seen across the GLP-1 RA class.
“These data show us that with a higher 2.0 mg dose of semaglutide, we can help even more adults living with type 2 diabetes, who are not at glycaemic control, lower their HbA1c.”
“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,” says Martin Lange, executive vice president of Novo Nordisk. “For almost a century, our mission has been to drive change in diabetes treatment and innovation to improve the lives of people living with diabetes. These data show us that with a higher 2.0 mg dose of semaglutide, we can help even more adults living with type 2 diabetes, who are not at glycaemic control, lower their HbA1c.”
A label extension application
On the basis of the primary results, Novo Nordisk previously announced submission of a label extension application to the European Medicines Agency (EMA) in December 2020, and to the US Food and Drug Administration (FDA) in May 2021, to evaluate an additional higher dose of 2.0 mg Ozempic for adults with type 2 diabetes.
Photo of Martin Lange: Novo Nordisk