Both scientific journals and mainstream media have lit up in recent weeks with big news of glucose-responsive insulin being developed by a team of researchers collaborating between the University of Utah and MIT (Massachusetts Institute of Technology).
Published on Feb. 9, this research, involving a new formulation of glucose-responsive insulin, is actually the latest step in work that stretches back decades; scientists have long been studying potential "smart insulin" that would automatically activate whenever blood sugars go too high or too low, self-regulating to keep blood sugars in range.
What sets this apart from other smart insulins in development is that they all use some type of protein gel or coating that stops the insulin from responding when low. But with the new so-called Ins-PBA-F concept, a chemical group known as PBA is attached instead, which servers to bind to the glucose and activate the insulin whenever needed. This method would also allow the insulin to stimulate cells to absorb any excess sugar in the system. Tests on mice show that one injection works for a minimum of 14 hours.
“Ins-PBA-F, acts more quickly, and is better at lowering blood sugar, than long-acting insulin detimir, marketed as Levemir. In fact, the speed and kinetics of touching down to safe blood glucose levels are identical in diabetic mouse models treated with Ins-PBA-F and in healthy mice whose blood sugar is regulated by their own insulin,” according to the study report.
"This is an important advance in insulin therapy. Our insulin derivative appears to control blood sugar better than anything that is available to diabetes patients right now,” research co-author Danny Chou of the University of Utah told that institute’s healthcare site.
The project has been in the works for about 3 years, says MIT scientist Matthew Webber, one of the lead authors on the research paper. They have roughly 20 people working on diabetes in the lab itself, and glucose-responsive insulin has been a focus for about five years now. Both the JDRF and Helmsley Charitable Trust helped fund this research.
OK, so they’ve only shown the benefits in mice so far… and we know how that goes. But they’re evaluating the long-term safety and efficacy of Ins-PBA-F now, and hope to reach Phase I human clinical trials in two to five years.
Oh, how wonderful it would be if insulin had a brain of its own, so that it actually responded to our blood sugars and self-adjusted instead of us having to do all that calculation, guess-work, and correcting when our sugars drop or spike! It might be the next best thing to a cure… some day.
A Dose of Background
Who can forget that less than a year ago, the D-Community was abuzz with excitement when Pharma giant Merck broke their four-year silence on their smart insulin R&D? Remember that in 2010 Merck acquired SmartCells, a Massachusetts-based startup that had been developing smart insulin for the better part of a decade.
It’s also worth noting that SmartCells creator Todd Zion came out of the very same MIT lab that is now dominating the news with this latest glucose-responsive insulin research.
Small world, apparently.
In an investor briefing in May 2014, Merck made mention of working on an investigational smart insulin (dubbed L-490 in the research), saying they were ready to move forward into Phase I human trials. But there wasn't much more detail provided other than an ETA for human clinical trials to begin by the end of 2014.
After that, the company pretty much went silent again on this front. We reached out many times during the past year for updates, but were told it would be premature to say anything before clinical studies occurred.
The good news is that those trials are underway. We scanned the U.S. clinical trial database and found Merck’s two-part study that began in November and is set to continue through July 2015, as of now based at one trial location -- the Profil Institute for Clinical Research in Southern California. A total of 58 patients are expected for enrollment, and the database shows people are still being recruited at this time.
From what we can tell from this study info, Merck’s smart insulin is being referred to as MK-2640.
Still, we're several years out to seeing anything substantial materialize -- if it ever does. So, for us on the potential receiving end, it's another box to check re: like to see but too early to get our hopes up.
Which Insulin to Bet On?
When we attended the Lilly Diabetes Summit in 2013, some of that company’s execs told a roomful of us advocates that we'd likely see faster insulins before we would see smart insulin. Their reasoning?
Smart insulin is "aspirational" and "over-hyped," and therefore big insulin-makers like Lilly, Novo, and Sanofi won't invested as much into that avenue as others have. Sure, they are exploring possibilities, but the big manufacturers appear to see super-fast-acting and improved long-acting insulins as their main priorities.
Of course you have to take that perspective with a grain of salt considering it’s jaded by their corporate goals. But you certainly can't deny all the research we've already seen on faster and generic insulins, and how far along that is compared to glucose-responsive insulin these days.
So, with all of all of that in mind, it's nice to be reminded that smart insulin is still in the works and on the minds of many researchers. Although like most things in the world of diabetes, hope and small scientific steps often get blow up into mainstream hype…
Here's to keeping it real, in these times of exciting D-research.