Novo Nordisk has announced positive headline results from Phase IIIb SUSTAIN FORTE trial of once-weekly semaglutide 1mg versus 2mg dose as an add-on to metformin and/or sulfonylureas in type 2 diabetes patients.
The trial met its primary endpoint by showing a statistically significant and superior reduction in HbA1c at week 40 with semaglutide 2mg as compared to 1mg dose.
The 40-week, efficacy and safety trial was conducted on 961 patients who needed treatment intensification.
At week 40, people who were given semaglutide 2mg achieved a statistically significant and superior reduction in HbA1c of 2.2% versus 1.9% with semaglutide 1mg.
About 68% of people treated with semaglutide 2mg achieved the American Diabetes Association (ADA) treatment target of HbA1c below 7% as compared to 58% in semaglutide 1mg group.
From a mean baseline body weight of 99.3kg, people treated with semaglutide 2mg had a statistically significant and superior weight loss of 6.9kg versus 6kg with semaglutide 1mg.
Both doses of semaglutide were observed to be safe and well-tolerated in the trial.
Novo Nordisk executive vice-president and chief scientific officer Mads Thomsen said: “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.
“This study demonstrates that patients in poor glycaemic control increase the likelihood of achieving their HbA1c target when treated with semaglutide 2mg.”
The SUSTAIN clinical development programme for a once-weekly subcutaneous semaglutide injection has 11 Phase III global clinical trials conducted on over 11,000 adults with type 2 diabetes.
This also includes a cardiovascular outcomes trial.
At present, Semaglutide 1mg is approved under the brand name Ozempic indicated for type 2 diabetes.