Novo Nordisk's Fast-Acting Insulin Fiasp Demonstrates Superior Glycemic Control in Children and Adolescents with Type 1 Diabetes

DiabetesNovo Nordisk, the industry giant, recently at the 44th International Pediatric and AdolescentDiabetes(ISPAD) AnnualMeetingData from the Phase IIIa clinical study ONSET-7 on Fiasp (fast-acting insulin aspart) were published. The data showed that, when used as part of a multiple daily injection regimen (also known as a basal-bolus regimen), Fiasp provided better glycemic control compared with conventional insulin aspart.

This study was a 26-week, partially double-blind, basal-bolus, treat-to-target study that enrolled 777 children and adolescents (aged 1 to <18 years) with type 1DiabetesThe efficacy and safety of Fiasp relative to conventional insulin aspart were evaluated in patients; the efficacy of Fiasp administered at mealtime (0–2 minutes before meal initiation) versus 20 minutes after meal initiation was investigated and compared with conventional insulin aspart administered at mealtime. All patients concurrently received basal insulin Tresiba (insulin degludec).

Data show that when administered at mealtimes, Fiasp achieved a greater reduction in overall glycemic levels (HbA1c) compared with the conventional insulin aspart treatment group (estimated treatment difference [ETD]: -0.17%). Furthermore, Fiasp also significantly reduced postprandial glucose levels (1 hour after meals) compared with conventional insulin aspart.

The study’s principal investigator, AtlantaDiabetesBruce Bode, a diabetes specialist from the Association, stated, “Fiasp has helped reduce the challenges of mealtime glucose control in adult patients with diabetes. Data from the ONSET-7 study show that Fiasp delivers similar benefits in children and adolescents with diabetes, which is highly exciting. These results indicate that Fiasp can provide an appropriate treatment option to effectively control blood glucose levels and better meet the needs of this specific population.”

In another group, patients who injected Fiasp 20 minutes after starting a meal achieved similar overall glycemic levels compared to those who injected conventional insulin aspart at mealtime (non-significant ETD: 0.13%, favoring conventional insulin aspart). This result confirms the non-inferiority of Fiasp when administered 20 minutes after starting a meal compared to conventional insulin aspart injected at mealtime.

Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk, stated, “For parents and caregivers of children with type 1 diabetes, it is difficult to know exactly how much or how quickly their child will eat, which makes timing and dosing of mealtime insulin injections challenging. The results of the ONSET-7 study demonstrate that Fiasp can reduce the burden of diabetes management during mealtimes for children and adolescents and their caregivers. We hope to make this treatment option available to this population as soon as possible so they may benefit.”

In terms of safety, Fiasp showed no significant differences compared with conventional insulin aspart in the overall incidence of severe or blood glucose-confirmed hypoglycemic episodes and other adverse events such as nausea or injection site reactions.

Fiasp is currently the only approved next-generation, ultra-rapid-acting mealtime insulin. It is a new formulation of insulin aspart (NovoRapid), with two new excipients (vitamin B3 and L-arginine) added to ensure more timely, rapid, and improved absorption, thereby enabling faster onset of action. Compared with insulin aspart, Fiasp more closely mimics the endogenous insulin response to meals, which represents the optimal approach to achieving HbA1c targets. To date, Fiasp has been approved in the United States, the European Union, Canada, Australia, Switzerland, and several other markets for improving glycemic control in adult patients with type 1 and type 2 diabetes.BioValleyBioon.com）