Hurry up, insulin!
How many times have we PWDs (people with diabetes) had that thought, wishing our darn insulin would kick in and start working to cover our food or bring down an unexpected glucose high?
Insulins still take anywhere from 30 minutes to an hour to really start working in these days, but there is a new option that science says could help speed up absorption: it's called Hylenex, an injectable liquid enzyme that basically makes the tissue under the skin less resistant to fluids -- like insulin -- so they can pass through and be absorbed more quickly into the blood vessels. So what used to take up to an hour to kick in could now, in theory, happen in just minutes!
Here's a product video that shows how Hylenex works (click on the screenshot below to see the video on Vimeo):
Where Has It Been?
OK, Hylenex isn't actually new; it's just experienced renewed interest of late as it relates to the impact on diabetes and insulin absorption.
Made by San Diego, CA-based biomedical company Haloyzme Therapeutics, the drug was first approved by the FDA almost eight years ago in December 2005 and was commercially launched for the U.S. in 2007, used most often to aid in the delivery of regional and local anesthesia. But a product recall in 2010 thanks to glass being found in vials (yikes!) led to a dip in interest and use.
And it's only recently that Hylenex has been discussed as a diabetes-specific solution, thanks to an industry focus on speeding up insulin activity and faster-acting insulins under development, according to well-known CDE and author Gary Scheiner, who called our attention to this drug.
Some new data was presented at this summer's annual meeting of the American Association of Diabetes Educators (AADE), and a Phase 4 clinical study is underway to examine how Hylenex works with insulin pumps. The drug is injected into the infusion set before connecting the pump tubing and starting insulin delivery, and it can help speed up the insulin absorption throughout the life of that infusion set (typically two or three days). About 400 patients are expected to be involved in the study that started in March 2013 and has an end-date set for September 2015, where everything from blood sugar spikes to A1C levels will be analyzed.
Basically, Hylenex could be one of the first new ultra fast-acting insulin approaches to be available to market depending on what happens with inhalable insulin Afrezza, which MannKind Corp. is getting ready to submit to the FDA for regulatory review and could be approved sometime in 2014. Afrezza is also being studied for use in an artificial pancreas system at the University of California Santa Barbara (we'll have more on that research soon, in a separate post.) So, the race for "fast-acting" insulin options is underway!
This sure sounds like it could be a very effective addition to a PWD's arsenal of meds! I know that it's one of the most frustrating things for me personally is trying to figure out how far in advance I need to take my meal boluses, in order to get the insulin to kick in and stop my blood sugars from skyrocketing. Depending on the type of food and a myriad of other factors, it's always a guessing game -- and a wonder that my CGM (continuous glucose monitor) graphs aren't even more out of whack than they are!
So, could Hylenex help?
Turns out that CDE and fellow type 1 Gary Scheiner is actually trial-testing Hylenex himself -- and says so far he's gotten mixed results.
He first tried out the drug in early September, but says that first attempt may not have worked because of possible exposure to heat (since there's no preservative in the vials, making it more susceptible to spoilage).
After a second try in mid-September, this is what Gary tells us:
"The jury is still out. At first, I did not see any effect on insulin action, based on CGM data following correction boluses. Still took 3.5 hours or so to bring my blood glucose down to normal. More recently, I'm seeing much better postprandial BGs -- less of a spike, which would indicate more rapid onset of insulin action. Next time I have an elevated reading, I'll study the action curve of the correction bolus again. Might be that the Hylenex works better in some parts of the body than others, or that it just takes time to work."
Maybe it's not a sure-fire fix, but Hylenex sounds like it does have potential... So we'll be waiting to anxiously to hear what comes out of the clinical trials, and what else Gary experiences in the near future.
If you too feel the need for speed when it comes to insulin action, this should be an interesting option to watch during the next couple of years!