Novo Nordisk: Final Trials Of Faster-Acting Insulin Aspart Meet Primary Point

(RTTNews) - Danish drug company Novo Nordisk (NVO) on Wednesday announced positive headline results from the final phase 3a trials for faster-acting insulin aspart.

According to the company, the onset 1 and onset 2 trials assessed the efficacy and safety of faster-acting insulin aspart compared with NovoRapid (insulin aspart) in a basal-bolus regimen in people with type 1 and type 2 diabetes, respectively.

Both trials achieved their primary objectives by demonstrating that treatment with faster-acting insulin aspart is non-inferior to NovoRapid with regard to lowering of HbA 1c, the company said.

For people with type 1 diabetes, the HbA 1c lowering achieved with faster-acting insulin aspart was statistically significantly larger than that achieved with NovoRapid when the insulins were given at mealtime.

Also, treatment with faster-acting insulin aspart was associated with less increase of postprandial glucose than NovoRapid during meal tests in both trials.

In both trials, the previously reported safety and tolerability profiles of faster-acting insulin aspart and NovoRapid were confirmed, and there were no apparent differences between the two treatment groups with respect to adverse events and other safety parameters.

Novo Nordisk said it expects to file faster-acting insulin aspart for regulatory review in the U.S. and EU around the turn of the year.