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A pair of studies presented at ADA 2021 detail the effects of an investigational 2.0 mg dose of semaglutide compared to semaglutide 1.0 mg (Ozempic) on glycemic control and body weight in patients with type 2 diabetes in SUSTAIN FORTE.
Outcomes data from the phase 3b SUSTAIN FORTE trial suggest the investigational 2.0 mg version of semaglutide provided greater reductions in HbA1c and body weight than semaglutide 1.0 mg (Ozempic).
With multiple studies related to primary outcomes and subgroups findings form the phase 3b trial, research presented at the American Diabetes Association’s 81st Scientific Sessions (ADA 2021) demonstrated the ability of semaglutide 2.0 mg once-weekly could provide greater reductions in HbA1c and body weight than the 1.0 mg version with a comparable safety profile.
”Some people living with type 2 diabetes require additional support to reach their blood glucose targets,” said Juan Frias, MD, Medical Director of the National Research Institute and principal investigator of SUSTAIN FORTE, in a statement from Novo Nordisk. “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."
With Novo Nordisk announcing the submission of a label extension application to the US Food and Drug Administration for the 2.0 mg dose in May 2021, data related to SUSTAIN FORTE, which was used as the basis of the application, were among the most anticipated at this year’s ADA conference. The data included a pair of studies, one detailing the overall efficacy and safety outcomes of the trial and the other detailing the effects of semaglutide 2.0 mg versus semaglutide 1.0 mg according to baseline bodyweight and HbA1c level.
A 40-week trial comparing once-weekly semaglutide 2.0 mg versus semaglutide 1.0 mg as add-on to metformin with or without sulfonylureas, SUSTAIN FORTE enrolled 961 patients with type 2 diabetes with an HbA1c of 8.0-10.0%. All patients in the trial initiated treatment with a 0.25 mg dose of semaglutide that was doubled every 4 weeks until the target dose was achieved.
The primary endpoint of the study was to provide evidence demonstrating the superiority of semaglutide 2.0 mg vs 1.0 mg on glycemic control. Investigators also sought to compare the effects of the investigational 2.0 mg dose effects on body weight, safety, and tolerability compared to the 1.0 mg dose.
Overall results of the trial indicted semaglutide 2.0 mg was associated with statistically significant and superior reductions in HbA1c (2.2% vs 1.9% [ETD, -0.23; 95% CI, -0.36 to -0.11; P <.001]) and body weight (-6.9 kg vs -6.0 kg [ETD, -0.93; 95% CI, -1.68 to -0.18; P=.016]) than the 1.0 mg dose. Additionally, the semaglutide 2.0 mg arm of the trial saw a greater proportion of patients achieve an HbA1c less than 7% (67.6% vs 57.5% [OR, 1.60; 95% CI, 1.21-2.13; P=.001]) or a body weight reduction greater than 5% (59.2% vs 51.3% [OR, 1.41; 95% CI, 1.08-1.84]) than the semaglutide 1.0 mg arm.
In the subgroup analysis, investigators assessed change in HbA1c and body weight based among those with an HbA1c of less than 9.0% versus 9.0% and above and those with a BMI less than 35 kg/m2 versus 35 kg/m2 and above. In these analyses, results demonstrated semaglutide 2.0 mg was associated with greater reductions in HbA1c and body weight compared to semaglutide 1.0 mg, irrespective of baseline HbA1c or BMI.
“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. “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 glycemic control, lower their HbA1c.”
These studies, “Efficacy and Safety of Once-Weekly Semaglutide 2.0 vs. 1.0 mg for Type 2 Diabetes: SUSTAIN FORTE Randomized Trial,” and“Efficacy and Safety of Once-Weekly Semaglutide 2.0 mg vs. 1.0 mg by Baseline HbA1c and BMI: SUSTAIN FORTE Subgroup Analyses,” was presented at ADA 2021.