A Demand for Better Glucagon Policies and Products

For those of us living with diabetes, severe low blood sugars requiring emergency help are always a possibility.

But the odds are unfortunately not in our favor that someone nearby will be able to respond properly and administer glucagon to save us.

Did you know it's 75% likely that a given EMT (emergency responder) would not be able to help because, in many places across the country, only those trained as Paramedics are qualified? Yikes!

It's pretty freakin' scary to have a restrictive policy in place like that -- especially given that scores of parents and partners of PWDs (people with diabetes) keep glucagon kits handy and have used them successfully on many occasions.

But then again, if you look at the complicated multi-step mixing process necessary with current glucagon products, it may not be a stretch to wonder why administering it is not officially allowed more widely.

As we move closer to getting an easier and less invasive type of glucagon on the market, there's a hope that the policy will also change and allow for more emergency personnel -- not to mention school officials -- to be authorized to administer it in case a PWD has a severe blood sugar.

Strict Rules on Glucagon Use

In late December 2017, a study from Joslin Diabetes Clinic found that only 1 in 4 PWDs experiencing an emergency are likely to get an EMT who would be able to give them glucagon. That study was published in the Annals of Internal Medicine.

“These restrictions are even more surprising given that glucagon is routinely administered by family members, and the side effects experienced by those receiving glucagon were not serious and most typically include nausea,” wrote Joslin Diabetes Center's Dr. Robert Gabbay, who co-authored this study.

On top of that, this study also noted that 911 dispatchers specifically alerted EMTs they would be responding to a PWD-related call in 44% of the observed incidents. Yet they were unprepared to respond properly.

This may seem shocking, but it's also the reality in many schools across the U.S., where teachers -- who are on the front-lines in the classrooms with students with diabetes -- are often not authorized to administer glucagon. Instead, many must send kids and teens to a school nurse -- if one is actually employed at the school. Otherwise, there are policies in place that require more oversight, something that can be very dangerous when a low blood sugar strikes.

Dr. Gabbay pointed to the need for more diabetes medical professionals to work with emergency medical personnel nationwide to design protocols for safe and effective use of glucagon.

Clearly, the existing policies need updating.

And if there were an easier-to-use glucagon on the market, it would certainly help on all fronts.

New Types of Glucagon Coming Soon

Given the complicated process of prepping current glucagon and the big scary needle required, we've all been anxiously awaiting a new way to administer glucagon for years now. Progress has unfortunately been slow; many promising products have either stalled in R&D or the startups producing them have vanished completely.

So we seem to have been at a standstill for the past few years. But just maybe we're now finally getting close to a new glucagon product on the market.

Glucagon Up Your Nose

Lilly Diabetes remains tight-lipped about the nasal (nose spray) glucagon it's had in the works for many years now.

This easy-to-use product developed by a company called Locemia and eventually acquired by Lilly has been in late-stage clinical trials for some time now. Heck, I puffed that Glucagon up my nose in as part of a trial back in early 2014.

But just recently at the big ATTD diabetes tech conference in Austria, this product had a presence but didn't seem to be much further along.

We do know that it will have a two-year shelf life and be much easier to use than what's available now, from both Lilly and Novo.

Some seem to believe this nasal glucagon could be submitted for regulatory approval with the FDA any time now, and possibly even start shipping in 2018, but that's all TBD and Lilly won't elaborate. So it's wait and see, for now.

Zealand Pharma's Dasiglucagon

Based in Denmark, Zealand Pharma has also been in the news lately with its novel glucagon called Dasiglucagon, a soluble glucagon formula that can be used in insulin pumps.

In fact, it's being tested in a dual-chambered pump that Beta Bionics is working on with its closed loop iLET device. The clinical trials for that remain ongoing and new research was presented recently at the ATTD conference overseas. Results of a longer Phase II clinical trial are expected later in 2018.

Dasiglucagon is also being developed in a ready-to-use rescue pen that could become a replacement for those complicated kits that are the only option now.

Clinical trials started on the pen version last year and results are expected later this year.

Finally, the company is also developing a specific glucagon product for the ultra-rare disease known as congenital hyperinsulinism (CHI), which strikes at birth and involves insulin being secreted irrespective of glucose levels. That product will go through late-stage clinical trials in mid-2018. 

Glucagon Products by Xeris

Chicago-based Xeris Pharmaceuticals made headlines recently by receiving an "Orphan Drug Designation" (ODD) from the FDA for its soluable glucagon product. That's an approval for a safe and effective treatment of rare diseases or disorders that affect fewer than 200,000 people in the U.S.

Xeris has received this nod for both its liquid-stable glucagon that will be available in an injector pen, as well as a mini-dose of its ready-to-use glucagon specifically for the treatment of hypoglycemia in patients who have just undergone bariatric surgery.

We've covered this over the years, but here's a refresher on what Xeris is developing:

• Rescue Pen: an auto-injector pen containing a single 200-unit dose of the company's stable glucagon formula, using proprietary tech it calls XeriSol. While the name may vary, it's been described as a "gluco" or "hypo" pen at different times. This would be a first-generation product with the "break the glass" in-case-of-emergency mindset, though the idea is to broaden the scope of how glucagon is thought of with this ready-to-use product.

• Glucagon Mini-Dosing: which contains the same formula of stable glucagon but is designed to allow smaller, multi-doses that can treat moderate hypos instead of the one-time quick boost.

• Pumpable glucagon: which will go inside an infusion pump and be dosed when blood sugars are low or dropping quickly.

Xeris recently announced results from Phase III research for its glucagon rescue pen, and that seems to be progressing nicely according to media reports.

Xeris CEO and President Paul Edick noted that it's on track to submit a New Drug Application to the FDA by mid-year, as it finishes a later-stage clinical trial focused on prep and administration time for the Xeris glucagon pen.

The hope is by end of 2018 or sometime in 2019, this could get regulatory approval and be ready to make it to market.

Still Waiting... even though #WeAreNotWaiting (?)

That's all great to hear, but it also sounds awfully familiar... Development seems to move so darn slowly.

“There is an urgent need for improved methods to treat severe hypoglycemia in this condition in order to maintain health, allow optimal nutrition, and improve safety,” said Dr. Mary-Elizabeth Patti of the Joslin Diabetes Center and Harvard Medical School. “Having a ready-to-use, liquid, stable glucagon option may provide health care professionals and patients alike more options to treat and prevent severe hypoglycemia.”

We couldn't agree more! And we certainly do hope to see a more modern, easy-to-use glucagon product before long -- which will surely help develop a national strategy for emergency responders and educators to be ready and able to treat when needed.

Let's face it: everyone on insulin is faced with danger of potentially deadly low blood sugars, so darn it -- we can't afford to drag our feet much longer on coming out with better ways prevent and handle those situations!

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This article was originally pjblished on DiabetesMine.