Scientists Discover New Ultrafast Insulin Formulation

The researchers at Stanford University are, currently, developing a new insulin formulation that starts acting almost immediately upon injection. They believe that it is likely to be four times faster than the existing commercial insulin formulations.

Individuals who have type 1 diabetes need exogenous insulin to regulate their blood glucose levels. Even though insulin has been used in diabetes treatment for almost a century, current rapid-acting insulin formulations are missing fast pharmacokinetics to maintain tight glycemic control during mealtimes.

To solve this shortcoming, experts at Stanford University developed a new formulation called ultrafast-absorbing insulin lispro (UFAL) that can reduce insulin aggregation and improve pharmacokinetics. In animal models, it enabled fast insulin absorption upon subcutaneous delivery and also improved the stability in response to stressed aging conditions.

"It felt like there was nothing happening and then all of a sudden there was this bright moment ... and a deadline a couple of months away. The moment we got an encouraging result, we had to hit the ground running,” MedicalXpress quoted Joseph Mann, the study’s co-lead author and a Ph.D. Candidate in Materials Science and Engineering at Stanford University.

While the commercially available fast-acting insulin formulations remain stable only around seven hours under stressed aging conditions, the new formulation offered stability for more than 24 hours. While it usually took at least 30 minutes for the commercial Humalog to start acting, the newly discovered insulin formulation exhibited peak action within 10 – 12 minutes.

"In terms of stability, we took a big step backward by making the insulin monomeric. Then, by adding our polymer, we met more than double the stability of the current commercial standard," MedicalXpress quoted the study’s co-lead author Caitlin Maikawa.

The research team plans to apply to the U.S. Food and Drug Administration (FDA) for approval to conduct human clinical trials. They are also considering other uses for their new formulation, having noticed how significantly it established stability.

And since this newly discovered insulin formulation activates so quickly and more like the hormone in individuals without diabetes, they are planning to explore if it could aid the development of an artificial pancreas device that could function without patient intervention during mealtimes.