Novo Nordisk today presented data showing that an investigational 2 mg dose of Ozempic® (semaglutide) injection provided statistically significant and superior reductions in blood sugar (A1C) compared with Ozempic®1 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 mg vs Ozempic® 1 mg as an 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)1,2 and the 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 mg with an elevated mean baseline A1C of 8.9% demonstrated a statistically significant and superior 2.2% reduction in A1C compared with a reduction of 1.9% seen with Ozempic® 1 mg after 40 weeks, when taken as intended.
Further post hoc subgroup analyses, presented at the congress, showed that semaglutide 2 mg demonstrated greater reductions in blood sugar at 40 weeks compared with Ozempic® 1 mg, across baseline A1C subgroups (Table 1).
"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 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 mg."
From a mean baseline body weight of 99.3 kg, semaglutide 2 mg demonstrated a statistically significant weight reduction of 6.9 kg compared with 6.0 kg with Ozempic®1 mg.† Based on the treatment policy estimand, people treated with semaglutide 2 mg experienced a statistically non-significant weight reduction of 6.4 kg compared with 5.6 kg with Ozempic® 1 mg. Further post hoc analyses presented across baseline BMI subgroups showed greater non-significant reductions in body weight with semaglutide 2 mg compared with the 1 mg dose (Table 1).2
The incidence of adverse events (AEs) was similar for both doses in the primary analysis and included gastrointestinal events (nausea, diarrhea, and vomiting). Gastrointestinal events are the most common AEs associated with GLP-1 RAs, including Ozempic®.
"Ozempic® has helped millions of people with type 2 diabetes worldwide lower their blood sugar, and although not indicated for weight loss, has demonstrated weight reduction for some patients. It has also helped reduce their risk of major cardiovascular events in adults with type 2 diabetes with established cardiovascular disease," said 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 mg dose of semaglutide, we can help even more adults living with type 2 diabetes, who are not at glycemic control, lower their A1C."
On the basis of the primary results, Novo Nordisk previously announced the 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 mg Ozempic® for adults with type 2 diabetes.
What is Ozempic®?
Ozempic® (semaglutide) injection 0.5 mg or 1 mg is an injectable prescription medicine used:
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