EASD 2019: ONSET 9 delivers positive data for Novo Nordisk’s Fiasp

GlobalData Healthcare 23rd September 2019 (Last Updated September 23rd, 2019 15:31)

Positive results were announced, indicating that Fiasp is a promising option for diabetes patients who require mealtime insulin.

Prandial insulin, such as Novo Nordisk’s NovoRapid/NovoLog (insulin aspart), is commonly prescribed to type 2 diabetes (T2D) patients who have difficulty lowering their blood glucose levels despite already being on oral diabetic therapy.

At the 55th annual European Association for the Study of Diabetes (EASD) meeting in Barcelona, Novo Nordisk’s Fiasp, an ultra-fast-acting insulin with an improved glucose-lowering effect compared to NovoRapid/NovoLog, was on the agenda.

Specifically, the focus was on the ONSET 9 trial, which evaluated the efficacy and safety of Fiasp compared with NovoRapid/NovoLog. Positive results were announced, indicating that Fiasp is a promising option for diabetes patients who require mealtime insulin.

The study was a 16-week, multicenter, double-blind, treat-to-target trial. Both treatment arms (Fiasp-treated and NovoRapid/NovoLog treated) were also treated with long-acting insulin, Novo Nordisk’s Tresiba (insulin degludec), with or without metformin. Trial results demonstrated a significant reduction from baseline hemoglobin A1c for T2D adult patients treated with Fisap compared to NovoRapid/NovoLog.

Specifically, Fiasp was deemed superior to NovoRapid/NovoLog given the significant reduction from baseline in one-hour postprandial glucose (PPG) following a meal test. Additionally, the overall lower rate of treatment-emergent severe blood glucose-confirmed hypoglycemia in Fiasp-treated patients versus patients treated with NovoRapid/NovoLog was statistically significant. A similar rate in the occurrence of severe hypoglycemia was observed within four hours after a meal.

In combination with Tresiba, Fiasp provided overall effective glycemic control, superior PPG control, and a lower rate of severe or blood glucose-confirmed hypoglycemia versus NovoRapid/NovoLog in T2D adults. Key opinion leaders interviewed by GlobalData previously indicated a preference for fast-acting insulin analogues (such as Fiasp) as part of a multiple-dose injection (MDI) therapy.

These promising results will provide physicians with more confidence when prescribing Fiasp as part of MDI therapy. Furthermore, a survey conducted by GlobalData found that 30% of physicians would favour switching from rapid-acting insulin analogues to ultra-fast formulations of the same insulin type as part of MDI. However, the success in achieving this market dominance and a high prescriber rate will rest on pricing, especially considering that the current NovoRapid/NovoLog has a significant price tag.

Related Report
GlobalData (2019). Type 2 Diabetes – Global Drug Forecast and Market Analysis to 2028, to be published