Trial examines high dose insulin treatment for people living with type 2 diabetes
Researchers suggest treatment could simplify management of the condition.
A recently published study has reviewed the effects of fast-acting, high dose insulin treatment for people living with type 2 diabetes.
The treatment method is viewed as offering better management of the condition for people who are insulin-resistant.
The study was carried out by researchers at Medical University of Graz in Austria and the results were recently published in Diabetes, Obesity and Metabolism.
Researchers used AT278, an investigational ultra-concentrated (500U/mL or U500) insulin aspart formulation produced by Arecor for tests on people with insulin-resistant type 2 diabetes who require high-dose therapy.
The results found that administering this treatment maintained its ultra-rapid pharmacokinetic (PK) and pharmacodynamic (PD) profile regardless of body mass index (BMI) levels, supporting its potential as the first ultra-rapid U500 insulin for people with insulin-resistant type 2 diabetes.
The article was the first time the complete study results have been published in a peer-reviewed scientific journal, following presentations at the annual meeting of the European Association for the Study of Diabetes (EASD) and the American Diabetes Association's (ADA) Scientific Sessions.
Researchers said: “In conclusion, our study demonstrates that AT278-U500 maintains its ultra-rapid onset characteristics independent of BMI (body mass index) in overweight and obese people with type 2 diabetes. By offering the first ultra-rapid U500 option for prandial dosing, AT278-U500 may represent a promising therapeutic advancement for severely insulin-resistant people with diabetes requiring high-dose insulin therapy.”
The findings showed that AT278 exhibited a significantly faster insulin absorption than both standard U100 concentration insulin aspart and U500 human regular insulin.
In addition, faster absorption led to a significantly greater glucose-lowering effect within the first hour following administration.
The treatment maintained its ultra-rapid onset characteristics independent of BMI, distinguishing it from standard insulin aspart.
As a result, insulin exposure and glucose-lowering activity remained comparable while maintaining a favourable safety profile.
The study said: “The obesity epidemic has grown to affect more than one billion people worldwide, with obesity as a major contributor to the development and progression of type 2 diabetes. In many obese people with type 2 diabetes, severe insulin resistance drives total daily insulin requirements beyond 200 units. For this population, concentrated insulins have become an essential therapeutic option. Available at two-fold to five-fold higher concentrations than standard U100 insulin (100 U/mL), concentrated insulins offer significant clinical advantages by reducing injection volume, number of injections, and injection-site discomfort, ultimately supporting treatment adherence.”
Dr Jan Jezek, CSO of Arecor, said: “The publication of the AT278-104 study in Diabetes, Obesity and Metabolism provides important peer-reviewed validation of our work advancing next-generation insulin formulations for people with high-dose insulin requirements. The study demonstrated that AT278 maintained its ultra-rapid PK and PD profiles in a high BMI type 2 diabetes patient population, addressing one of the longstanding challenges associated with concentrated insulin therapies.
“With obesity now affecting more than one billion people worldwide and insulin resistance continuing to increase globally, more people are developing type 2 diabetes. In many obese people with type 2 diabetes, severe insulin resistance results in high total daily insulin requirements. The US average daily insulin dose for this patient population is 100 units, making concentrated ultra-rapid-acting insulin an essential therapeutic option.
“We believe these findings support the potential for AT278 to become the first ultra-rapid U500 insulin for prandial use while also reinforcing the important role that advanced insulin formulations will play in enabling smaller, longer-wear fully automated insulin delivery systems that simplify diabetes management, reducing burden and improving outcomes.”
Read the report in Diabetes, Obesity and Metabolism
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