I'm struggling to understand the low bar for success for Dasiglucagon


#1

How can success be a mere 20 mg/dl rise in bg’s??

" 168 people with type 1 diabetes participated in this trial, and success was defined as a 20 mg/dl increase in blood glucose levels. "


#2

I guess it all hinges on the context of the hypo. If a hypo treated at 54 (3.0) headed toward 34 (1.9) but the glucagon treatment instead turns that around into a rise to 74 (4.1), a rise of 20 mg/dL (1.1 mmol/L), then I definitely see that as a success.

Alternately, if a glucagon treatment can only result in turning a 34 (1.9)into 54 (3.0) then that doesn’t seem like a good outcome.

As a side issue, I’d like to see more energy put into a system capable of mini-glucagon doses. I’d love to have a pen that I could dial up the small dose I wanted to turn around a trending hypo. Why do we have to wait for a pump company to debut the glucagon use as part of a more sophisticated and complicated system?

I love that these new glucagon products are focusing on emergency glucagon. Why are they also not showing an interest in mini-glucs? It’s the money, I’m sure, but I think it’s ignorance of the market, too.


#3

I’ve gotten rises of over 250 points from glucagon injections; hence my question regarding a mere 20 point rise. Is this stuff a much smaller dosage than what we used back in the 1980’s?


#4

That article isn’t very clear.
Then again, the other articles are not very clear either.
Here is a snippet that clarifies it a little better.
“” The primary endpoint was time to plasma glucose recovery, which was defined as first increase in plasma glucose of >/=20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose’"
This, to me at least, is saying the FIRST increase of 20 mg/dl. Not the overall increase.
Meaning, that in 10 minutes the BG raised by 20. It doesn’t say what the overall increase was.

Snippet was taken from:


#5

They are showing an interest. Xeris, the same company who has submitted FDA approval for a glucagon autoinjector and who is working on pump-compatible glucagon, is also working on a mini-dose pen that’s essentially the same type of design as an insulin pen.

Here’s one of their studies (they have done multiple studies).


#6

I think a 20 point rise is perfect. In pretty much any circumstance.

Depending on what you consider a hypo:

  • Going from 69 to 89, perfect.

  • Going from 50 to 70, that’s great. You can have a few carbs to go from there.

  • Even if you are on death’s doorstep and are 30, if it brings you back to 50 and brings you back to consciousness, you can eat something and correct back up from the 50 to wherever you want to be.

I would rather have a 20 point rise instead of a 200 point rise every single time. That would be my preference in all circumstances. I think it’s great!


#7

Again, I think they are only using a 20 point rise as a metric only.
This can hit the first 20 point rise in 10 minutes, whereas the current options take 12 minutes.


#8

I’d rather have a product that did what the glucagon kits of yesteryear did–bring one back from “the brink of death”. I’ve been there; done that, thanks to an accidental injection into a vein. My number was nearly up that day. AAMOF, the attending physician said that only about 1/2 of those that do that, survive. I don’t doubt it–I felt like I was a FEW SECONDS from dying and believe u me, I’ve had plenty of lows over the years. A kit that had the potential to be a life saver when super, super low can ALWAYS BE PARTIALLY USED for a less dangerous low.


#9

These new stable liquid formulations seem to all be in autoinjector format. You can’t take a partial dose of a medication delivered by autoinjector—not unless you can find some way of taking it apart (without inadvertently triggering delivery) and extracting the medication.

Based on this study, which I’m not sure is the same study as mentioned int he article but is about the same product, this new glucagon has similar characteristics as the currently available glucagon:

Dasiglucagon was well tolerated and showed an early PD response similar to that of GlucaGen at corresponding doses, suggesting comparable clinical effects of the two glucagon formulations.

The study abstract also says that peak glucose concentrations were reached in 35 minutes, which suggests that the first 10 minutes (20 mg/dl) rise was just a target they were looking at and not the extent of the glucagon’s glucose-rising effect.


#10

Jen - The link you tried to post is inop. I will follow if you repost.


#11

I hate when they do that–limit a dosage to their chosen amount.


#12

That’s the whole point of an autoinjector, though. It’s just designed to be as easy to use as possible. No fiddling with doses or mixing stuff. It’s so easy that you may even be able to do it yourself before passing out, if no help were around.


#13

I’ve edited my post and it should work now. Apparently Discourse doesn’t like HTML anymore.


#14

one can have “ease of use” and options. They aren’t mutually exclusive and when a mfgr decides to remove all options–I don’t like that.


#15

If a person feels like they’re a few seconds from dying, they may not want to be faced with options and decision-making. Grab and inject would work for me – or for those who have to do it for me.


#16

I agree here. I don’t want my wife (or stranger for that matter,) having to think about how much to give.
Just stab me with the darn thing and save my sorry butt!

That being said, I would like to have one for my own use where I COULD give small doses. I would rather use this then continually have to EAT MORE CARBS to stay balanced (read, not all the time, but those times when you want a FAST pickup, but only need 20 to 50 point rise.)


#17

I met with my new super-young endo for the first time today and she couldn’t believe I was still using insulin vials and syringes instead of pens. I tried explaining how I’d been using plastic syringes for longer than she’d been alive and that they originally trained me on glass syringes!

The world really has moved on to pens and autoinjectors or at least the marketing has.


#18

Like @beacher said, the whole point of an autoinjector is to provide a way to deliver a medication as quickly as possible in a life-threatening situation, even by people with minimal or no training. So, at least for the situations these things are designed for, having a pre-measured dose is actually a feature.

I agree that it would be nice to have a glucagon pen that allows dosing for non-life-threatening lows. But luckily that should come in the future as well, since at least one manufacturer is working on both an autoinjector and a mini-dose pen.


#19

I”m probably as young as your endo, and though I’ve used syringes, I definitely prefer pens (though that’s at least in part because I can’t see to use syringes). I’m looking forward to the Bluetooth-capable pens that Novo Nordisk is coming out with in the near future.

I’m also looking forward tot he autoinjector, but I’m happy that it won’t be the only delivery method to choose from. Hopefully ten years down the road we’ll be able to choose whether we want an autoinjector, nasal spray, mini-dose pen, glucagon in our pump, the traditional kits (I’m sure they’re not going easy anytime soon), or more than one of these options.


#20

Looking on the Epinephrine side of the fence, the Epipens are several hundred dollars but prefilled epiniphrene syringe kits (sold only to medical professionals and not to end users) are only $10. I’m amazed that the convenience is worth a 30 times increase in price. I think the Epipen patent is not on the drug but on the injector,?

On the insulin side of the fence, several newer insulins (like my Tresiba) are available only in pens. No vials. So it’s not obvious that any new product might be available in a wide variety of containers.