Two phase III trials of NN 9535 (semaglutide subcutaneous) show improved glycaemic control in type 2 diabetes- Novo Nordisk

Findings from two phase IIIa clinical trials for NN 9535 (semaglutide subcutaneous), from Novo Nordisk, were presented at the American Diabetes Association 76th Scientific Sessions. In the SUSTAIN 2 trial, 0.5 mg and 1.0 mg semaglutide administered once-weekly significantly improved glycaemic control compared to sitagliptin (100 mg), a dipeptidyl peptidase-4 (DPP-4) inhibitor, in adults with type 2 diabetes. In the SUSTAIN 3 trial, 1.0 mg semaglutide administered once-weekly significantly improved glycaemic control compared to 2.0 mg exenatide extended-release (ER), a GLP-1 receptor agonist, in adults with type 2 diabetes. The SUSTAIN 2 trial showed that from a mean baseline HbA1c of 8.1%, adults with type 2 diabetes treated with 0.5 mg and 1.0 mg semaglutide achieved superior HbA1c reductions of 1.3% and 1.6%, respectively, vs 0.5% with 100 mg sitagliptin at 56 weeks, as add-on to metformin and/or thiazolidinediones.

In the 56-week SUSTAIN 3 trial, adults with type 2 diabetes and a mean baseline HbA1c of 8.3% achieved a superior HbA1c reduction of 1.5% when treated with 1.0 mg semaglutide vs 0.9% with 2.0 mg exenatide ER, as add-on to one or two oral antidiabetics (metformin, sulfonylurea or thiazolidinediones). More adults with type 2 diabetes achieved the HbA1c target of below 7% when treated with 0.5 mg and 1.0 mg semaglutide vs sitagliptin in SUSTAIN 2 (69% and 78% vs 36%) and with 1.0 mg semaglutide vs exenatide ER in SUSTAIN 3 (67% vs 40%).

In addition, from a mean baseline body weight of 89.5 kg, adults with type 2 diabetes achieved significantly greater reductions in mean body weight when treated with 0.5 mg and 1.0 mg semaglutide vs sitagliptin in SUSTAIN 2 (4.3 kg and 6.1 kg vs 1.9 kg). Similarly, from a mean baseline body weight of 95.8 kg, adults with type 2 diabetes achieved significantly greater reductions in mean body weight when treated with 1.0 mg semaglutide vs exenatide ER in SUSTAIN 3 (5.6 kg vs 1.9 kg). In SUSTAIN 2, the most common adverse events observed for adults treated with 0.5 mg and 1.0 mg semaglutide and sitagliptin were gastrointestinal (43.5% and 39.9% vs 23.6%). Similarly, in SUSTAIN 3, the most common adverse events observed for adults treated with 1.0 mg semaglutide and exenatide ER were also gastrointestinal (41.8% and 33.3%).

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.