Investigational 2.0 mg dose of once weekly Ozempic demonstrates superior reductions in blood sugar vs Ozempic 1.0 mg in type II diabetes – Novo Nordisk

Novo Nordisk presented data showing that an investigational 2.0 mg dose of Ozempic (semaglutide) provided statistically significant and superior reductions in blood sugar (HbA1C) compared with Ozempic 1.0 mg. These data were the outcome of the SUSTAIN FORTE trial, a phase IIIb, 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. The results were presented at the 81st Annual Scientific Sessions of the American Diabetes Association (ADA) and primary results are in press for publication in The Lancet Diabetes & Endocrinology.

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 subgroups1,2. This is consistent with AEs seen across the GLP-1 RA class.

“Some people living with type 2 diabetes require additional support to reach their blood glucose targets,” said Dr 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.”.

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 FDA in May 2021, to evaluate an additional higher dose of 2.0 mg Ozempic for adults with type 2 diabetes.

See- Frias J, Auerbach P, Bajaj H, et al. “Efficacy and Safety of Once-Weekly Semaglutide 2.0 vs 1.0 mg for Type 2 Diabetes: SUSTAIN FORTE Randomized Trial”. Presented during the 81st Scientific Sessions of the American Diabetes Association: Oral 101-OR.