Data from Pharmawand - Curated by Toby Galbraith - Date added 30 March 2015
Novo Nordisk has announced headline results from the final Phase IIIa trials for faster-acting insulin aspart, ONSET 1 and ONSET 2. The trials investigated 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 HbA1c. For people with type 1 diabetes, the HbA1c lowering achieved with faster-acting insulin aspart was statistically significantly larger than that achieved with NovoRapid when the insulins were given at mealtime. In addition, 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.
Comment: Novo Nordisk’s FIAsp is the ultra-rapid-acting insulin that follows behind Afrezza (an ultra-rapid-acting inhaled mealtime insulin for people with type 1 and type 2 diabetes) from Sanofi (formerly Mannkind). Afrezza is now approved in both FDA and EU in 2014.