Novo Nordisk presented data for 2 mg dose of Ozempic at the 81st Annual Scientific Sessions of the American Diabetes Association.
An investigational 2 mg dose of semaglutide (Ozempic; Novo Nordisk) injection showed statistically significant and superior reductions in blood sugar (A1C) compared with semaglutide 1 mg dose in a recent study. Data from the phase 3b SUSTAIN FORTE trial (NCT03989232) were presented during the virtual the 81st Annual Scientific Sessions of the American Diabetes Association (ADA).
The SUSTAIN FORTE trial is a 40-week, efficacy and safety study comparing once-weekly semaglutide 2 mg vs semaglutide 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. According to Novo Nordisk, the trial met its primary endpoint, in which people treated with once-weekly semaglutide 2 mg with an elevated mean baseline A1C of 8.9% demonstrated a 2.2% reduction in A1C compared with a reduction of 1.9% seen with semaglutide 1 mg after 40 weeks.
"Some people living with type 2 diabetes require additional support to reach their blood glucose targets," said principal investigator Dr Juan Pablo Frias, medical director of the National Research Institute, Los Angeles, in a press release. "The reductions in blood glucose seen with semaglutide 2 mg demonstrate that a higher dose of [semaglutide] may offer individuals the opportunity to further improve their diabetes control, with comparable tolerability to [semaglutide] 1 mg."
According to Novo Nordisk, 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 semaglutide 1 mg. Based on the treatment policy estimated, individuals treated with semaglutide 2 mg experienced a statistically nonsignificant weight reduction of 6.4 kg compared with those taking 5.6 kg with semaglutide 1 mg.
"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, in a press release. "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."
The incidence of adverse events (AEs) was similar for both doses in the primary analysis and included gastrointestinal events such as nausea, diarrhea, and vomiting. Gastrointestinal events are the most common AEs associated with GLP-1 RAs, including semaglutide, according to Novo Nordisk. Possible serious AEs include thyroid tumors.
Investigational 2 mg dose of Ozempic (semaglutide) injection demonstrates superior reductions in blood sugar vs Ozempic 1 mg in adults with type 2 diabetes in a phase 3 trial [news release]. June 26, 2021; Novo Nordisk. [email]