Once-weekly semaglutide 2.0 mg demonstrates superior reduction in HbA1c vs once-weekly semaglutide 1.0 mg in people with type 2 diabetes in the SUSTAIN FORTE trial,- Novo Nordisk

Novo Nordisk announced headline results from the SUSTAIN FORTE trial, a phase IIIb 40-week, efficacy and safety trial with once-weekly semaglutide 2.0 mg vs once-weekly semaglutide 1.0 mg as add-on to metformin and/or sulfonylureas in 961 people with type 2 diabetes in need for treatment intensification The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c at week 40 with semaglutide 2.0 mg compared to semaglutide 1.0 mg. When evaluating the effects of treatment taken as intended1 and from a high mean baseline HbA1c of 8.9%, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c of 2.2% compared with a reduction of 1.9% with semaglutide 1.0 mg at week 40. The American Diabetes Association (ADA) treatment target of HbA1c below 7.0% was achieved by 68% of people treated with semaglutide 2.0 mg vs 58% on semaglutide 1.0 mg. From a mean baseline body weight of 99.3 kg, people treated with semaglutide 2.0 mg experienced a statistically significant and superior weight loss of 6.9 kg compared with 6.0 kg with semaglutide 1.0 mg. When applying the treatment policy estimand, people treated with semaglutide 2.0 mg experienced a reduction in HbA1c of 2.1% compared to 1.9% for people treated with 1.0 mg dose at week 40. People treated with semaglutide 2.0 mg experienced a statistically non-significant weight loss of 6.4 kg compared with 5.6 kg with semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared safe and well-tolerated. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg with nausea rates around 15% for both doses. The treatment discontinuation rates due to adverse events were similar and below 5% for both doses of semaglutide..