Novo Nordisk today announced headline results from the SUSTAIN FORTE trial, a phase 3b 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 significant1 and superior weight loss of 6.9 kg compared with 6.0 kg with semaglutide 1.0 mg.
When applying the treatment policy estimand2, 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.
|Trial product estimand||Treatment policy estimand2|
|Once-weekly semaglutide||2.0 mg||1.0 mg||2.0 mg||1.0 mg|
|Body weight reduction||6.9 kg*||6.0 kg||6.4 kg||5.6 kg|
*Statistically significant vs once-weekly 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.
"We are very pleased with the results from the SUSTAIN FORTE trial with the large HbA1c reduction from a high baseline as well as the safety and tolerability profile, which establish a attractive benefit-risk ratio for treatment of type 2 diabetes with semaglutide" said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "Semaglutide 1.0 mg has across the SUSTAIN programme demonstrated that up to 80% of patients achieved HbA1c levels below 7%. This study demonstrates that patients in poor glycaemic control increase the likelihood of achieving their HbA1c target when treated with semaglutide 2.0 mg."