Therapy Areas: Cardiovascular
Investigational 2 mg Dose of Ozempic Injection Demonstrates Superior Reductions in Blood Sugar vs Ozempic 1 mg in Adults with Type 2 Diabetes in a Phase 3 Trial
28 June 2021 - - Danish pharmaceutical company Novo Nordisk (NYSE: NVO) has presented data showing that an investigational 2 mg dose of Ozempic (semaglutide) injection provided statistically significant and superior reductions in blood sugar compared with Ozempic 1 mg, the company said.

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 1,2 and the primary results are in press for publication in The Lancet Diabetes and 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.

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).

The incidence of adverse events 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.

On the basis of the primary results, Novo Nordisk previously announced the submission of a label extension application to the European Medicines Agency in December 2020, and to the US Food and Drug Administration in May 2021, to evaluate an additional higher dose of 2 mg Ozempic for adults with type 2 diabetes.

Ozempic (semaglutide) injection 0.5 mg or 1 mg is an injectable prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes mellitus with known heart disease.
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