Phase IIIa trial for NN 9535 (semaglutide subcutaneous) meets objective in type 2 diabetes- Novo Nordisk

Novo Nordisk announced the headline results from the fifth phase IIIa trial for NN 9535 (semaglutide subcutaneous), SUSTAIN5. The double-blinded trial investigated the efficacy and safety of 0.5 mg and 1.0 mg semaglutide compared with placebo as add-on to basal insulin alone or basal insulin in combination with metformin, after 30 weeks of treatment in 397 people with type 2 diabetes.

The trial successfully achieved its objective by demonstrating that people treated with 0.5 mg or 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.4% and 1.8% respectively, from a mean baseline HbA1c of 8.4%, compared with an improvement in HbA1c of 0.1% with placebo.

Additionally, the end of trial insulin dose for people treated with 0.5 mg and 1.0 mg semaglutide was reduced by 10% and 15% respectively, compared with 3% for the placebo group. 61% of the people treated with 0.5 mg semaglutide and 79% of the people treated with 1.0 mg semaglutide achieved the treatment target of HbA1c below 7% set by the American Diabetes Association and the European Association for the Study of Diabetes, compared with 11% of the people treated with placebo. From a mean baseline body weight of 92 kg, people treated with 0.5 mg and 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 3.7 kg and 6.4 kg respectively, compared with a weight loss of 1.4 kg for people treated with placebo. In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse event was nausea.

Comment: Along with NN 9535, the oral daily version of Novo's semaglutide, called OG 217SC, could impact radically on the GLP-1 market. Already, its Victoza daily GLP-1 injection is market leading with $2 billion annual sales.