For children and adolescents aged between one and 18 years living with Type 1 diabetes, Fiasp® could be an option to better manage their blood sugar levels, when used as part of a multiple daily injection routine (also known as a basal-bolus regimen).
New data presented at the 44th Annual Conference of the International Society for Pediatric and Adolescent Diabetes (ISPAD) showed that the study population receiving this ultra-fast-acting formulation of insulin aspart achieved superior reductions in overall blood sugar levels (HbA1c), compared with the group being treated with conventional insulin aspart when both treatments were dosed at meal times with an estimated treatment difference (ETD) of -0.17%.
In addition, significantly lower overall post-meal blood sugar levels (1-hour after the meal) were achieved with Fiasp® compared with conventional insulin aspart.
Diabetes specialist at Atlanta Diabetes Associates and lead researcher of the study Dr Bruce Bode said: “Fiasp® has already helped to reduce challenges around mealtime blood sugar control for adults with diabetes, and it is exciting to see that similar benefits are achieved with children and adolescents in this trial.
“These findings show that Fiasp® may offer a suitable option to improve blood sugar control and better meet the needs of this specific population.”
Another group of study participants that injected Fiasp® 20 minutes after the start of a meal, achieved similar overall blood sugar levels to those taking conventional insulin aspart dosed at mealtime (non-significant ETD of 0.13% in favour of conventional insulin aspart). These results confirm the non-inferior profile of action of Fiasp® when dosed 20 minutes after the start of the meal, compared with conventional insulin aspart dosed at mealtime.
Executive vice-president and chief science officer of Novo Nordisk Mads Krogsgaard Thomsen said: “It can be hard for the parents and caregivers of children with Type 1 diabetes to know exactly how much or how fast their children will eat, making the dosing of mealtime insulin challenging in relation to both timing and quantity.
“These results show that Fiasp® may be able to ease some of the burden of diabetes management at meal times for children and adolescents, as well as those who care for them. We hope to make this ultra-fast treatment option available to benefit this population as soon as possible.”
There were no significant differences in the overall rate of severe or blood-sugar confirmed hypoglycemic episodes, or overall rates of other adverse events such as nausea or injection site reactions, confirming the safety profile of Fiasp® in comparison to conventional insulin aspart.
About the study
The onset 7 trial was a 26-week, phase 3a, partially double-blinded, basal-bolus, treat-to-target study that enroled 777 people. Aiming to evaluate the efficacy and safety of Fiasp® compared with conventional insulin aspart in children and adolescents with Type 1 diabetes, the study investigated Fiasp® dosed at mealtimes nought to two minutes before starting the meal and 20 minutes after the start of the meal. This was compared with conventional insulin aspart dosed at mealtimes nought to two minutes before starting the meal.
All treatment arms involved a multiple daily injection routine (basal-bolus) using Tresiba® (insulin degludec) as the basal insulin.
Fiasp® is an approved, new-generation, ultra-fast acting mealtime insulin injection.
The drug is made from insulin aspart in an innovative formulation that sees Vitamin B3 (niacinamide) added to increase the speed of absorption and a naturally occurring amino acid (L-Arginine) added for stability. The result is a mealtime insulin that more closely mimics the natural physiological insulin response of a person without diabetes after a meal, compared with conventional insulin aspart.
Fiasp® is approved in markets such as the US, Canada, Switzerland, Australia and the EU, including Norway and Iceland. It is also currently under regulatory review in several other countries worldwide. Fiasp® is currently indicated for the treatment of adults with Type 1 and Type 2 diabetes only.