Researchers at Stanford University are developing a new insulin formulation that begins to take effect almost immediately upon injection, potentially working four times as fast as current commercial fast-acting insulin formulations.
The researchers focused on so-called monomeric insulin, which has a molecular structure that, according to theory, should allow it to act faster than other forms of insulin. The catch is that monomeric insulin is too unstable for practical use. So, in order to realize the ultrafast potential of this insulin, the researchers relied on some materials science magic.
After screening and testing a large library of additive polymers, the researchers found one that could stabilize monomeric insulin for more than 24 hours in stressed conditions. (By comparison, commercial fast-acting insulin stays stable for six to 10 hours under the same conditions.) The researchers then confirmed the ultrafast action of their formulation in diabetic pigs. Their results were published in Science Translational Medicine. Now, the researchers are conducting additional tests in hopes of qualifying for clinical trials in humans.
The researchers plan to apply to the U.S. Food and Drug Administration (FDA) for approval to test their insulin formulation in clinical trials with human participants (although no trials are planned, and they are not seeking participants at this time). They are also considering other uses for their polymer, given how significantly it increased stability in commercial insulin.
Because their insulin formulation activates so quickly – and, therefore, more like insulin in a person without diabetes – the researchers are excited by the possibility that it could aid the development of an artificial pancreas device that functions without the need for patient intervention at mealtimes.
