Phase III SUSTAIN 4 trial shows improvements with NN 9535 (semaglutide) in type 2 diabetes- Novo Nordisk

Findings from a phase IIIa clinical trial for NN 9535 (semaglutide), from Novo Nordisk, demonstrated that treatment with subcutaneous semaglutide, administered once-weekly, significantly improved glycemic control compared to insulin glargine U100 in adults with type 2 diabetes. The 30-week SUSTAIN 4 trial showed that, from a mean baseline HbA1c of 8.2%, adults with type 2 diabetes receiving metformin with or without sulfonylurea, achieved statistically significant and superior improvements in HbA1c reductions of 1.2% and 1.6% when treated with 0.5 mg and 1.0 mg semaglutide, respectively, vs a 0.8% reduction with insulin glargine U100. End of trial mean dose of insulin glargine U100 was 29 IU/day.

More adults treated with 0.5 mg and 1.0 mg semaglutide achieved HbA1c targets compared with insulin glargine U100: HbA1c less than 7% (57.5% and 73.3% vs 38.1%) and more than 6.5% (37.3% and 54.2% vs 17.5%). Additionally, from a mean baseline body weight of 93.4 kg/205.91 lb, adults treated with 0.5 mg and 1.0 mg semaglutide achieved statistically significant and superior reductions in mean body weight of 3.5 kg/7.72 lb and 5.2 kg/11.46 lb compared to an increase of 1.2 kg/2.65 lb with insulin glargine U100.

The most common adverse events observed for adults treated with 0.5 mg and 1.0 mg semaglutide were gastrointestinal (nausea: 21.3% and 22.2% vs insulin glargine U100, 3.6%; diarrhea: 16.3% and 19.2% vs insulin glargine U100, 4.4%; vomiting: 6.6% and 10.3% vs insulin glargine U100, 3.1%). Results from the SUSTAIN 4 trial were presented at the American Association of Clinical Endocrinologists 25th Annual Scientific and Clinical Congress .

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.