Fast-Acting Insulin - Almost a reality

[Darryl]

I've commented on this in other posts recently, but think it is signficant enough to start a separate thread.

Biodel (www.biodel.com (http://www.biodel.com)) has developed an insulin called ViaJect that is in phase 3 trials, currently being tested by 400 T1 and 400 T2 volunteers.

Viaject is actually humalog, but with the addition of other ingredients that make it absorb quickly, act in 15 minutes, and be out of your system in about an hour.

There was a post on this a year ago by badshoe. Biodel is a lot closer now to getting to market, having successfully completed phase 1 and 2 trials, and now with phase 3 underway. They claim in their press release that they will seek FDA approval around year-end.

The implications of fast-acting insulin are potentially astounding to those of us who treat T1 diabetes daily:


Near-immediate correction of high's, with the ability to know in less than 30 minutes if the correction was sufficient or excessive.
Greatly improved post-prandial response, much closer to the body's natural insulin response to food.
Lower risk of hypoglycemia, since basal changes will take effect in minutes, not hours.
Possibly the enabling technology for closed-loop artifical pancreas technology.

In case you are wondering, I do not work for Biodel. I have been watching them closely though! I think that everyone here should be aware of the possibilities and make sure our endo's are aware as well so that it can get into the pipeline at and get insurance coverage after approval.

[Twinklet]

Very interesting! Thanks for posting this!

[Jacob'sDad]

While I think this insulin will have it's advantages I don't think it will be a magic bullet. Almost all meal boluses will have to be given as a combo bolus and all the combos will have to be tailored to match the absorption rate of the food just eaten. For many pumpers this may be too complicated. I'll bet many will stick with what they have.

[kel4han]

Yeah, I dont know. This quick acting would be scary for kids. I'm all good to try it on myself, but I would be scared of serious hypo's if not matched to the food digestion just right. I know I personally don't spike anywhere near how my daughter spikes, so then again it could work. Still scary though.

[selketine]

I wonder how this will work for pumpers?

Some pumps deliver more of the basal at once don't they? Seems like 4 yrs ago when we were shopping I remember the MM rep questioning whether Animas could really spread a .05 basal rate out the way they do over an hour.

Seems like if the insulin had such immediate effect there would be some oddness with using it for basal insulin.

On the other hand it would be nice to see if a correction worked and not have it working for 3 more hours after I go to bed.

I agree that combos would be a HUGE issue though - we'd definitely need them.

[Jacob'sDad]

I wonder how this will work for pumpers?

Some pumps deliver more of the basal at once don't they? Seems like 4 yrs ago when we were shopping I remember the MM rep questioning whether Animas could really spread a .05 basal rate out the way they do over an hour.



I don't believe it can and Jacob uses an Animas pump. I believe the mechanism that moves the plunger down on the cartridge does move but it's hard to believe that this microscopic amount of insulin comes out. It's far more likely that it builds up and releases in larger amounts spread further apart, but with the insulin's slow action time it just evens out over time. In other words the average amount given in an hour could indeed be .05 units even though it is not perfectly spread out over that hour, and for all practical purposes it doesn't matter. With super fast acting it MAY INDEED MATTER. It's like insulin with NO CUSHION.

[frizzyrazzy]

While I think this insulin will have it's advantages I don't think it will be a magic bullet. Almost all meal boluses will have to be given as a combo bolus and all the combos will have to be tailored to match the absorption rate of the food just eaten. For many pumpers this may be too complicated. I'll bet many will stick with what they have.
while I do think that quicker insulins are needed, I totally agree with your assessments. I think we'll have have to completely change our mindset on how insulin works and adjust boluses quite considerably. Without proper training on this, many people will flounder. It will be like relearning diabetes. Yes, that might be good. Maybe there will come a day when combo bolus and the MDI equivalent is taught at diabetes 101 in the hospital - that it isn't relegated to the realm of "advanced techniques". I would love faster insulins for so many reasons.

[wilf]

I'm sure people had similar concerns about Novolog/Humalog when they came out. As far as i'm concerned, this would be a great step forward esp. for correcting highs.

[Jacob'sDad]

I'm sure people had similar concerns about Novolog/Humalog when they came out. As far as i'm concerned, this would be a great step forward esp. for correcting highs.

I was just thinking that if a person wanted to stick with slower acting in the pump they could still use this stuff in a syringe to correct a high. That is as long as mixing the two in the body is OK. Since it's really Humalog it should be OK, right?

[Kaylee's Mommy]

I think this would be great as a correction.. BUT I know how Kaylee eats, and Icould just see a disaster with dosing for meals with something so fast acting.. although, in an ideal world, I think it would be great (but then again, in an ideal world, we wouldn't be dealing with D..:rolleyes: )

[Darryl]

I don't believe it can and Jacob uses an Animas pump. I believe the mechanism that moves the plunger down on the cartridge does move but it's hard to believe that this microscopic amount of insulin comes out. It's far more likely that it builds up and releases in larger amounts spread further apart, but with the insulin's slow action time it just evens out over time. In other words the average amount given in an hour could indeed be .05 units even though it is not perfectly spread out over that hour, and for all practical purposes it doesn't matter. With super fast acting it MAY INDEED MATTER. It's like insulin with NO CUSHION.

The replies have been very enlightening as to what we'd need to watch out for with faster insulin.

I can say for certain that the Omnipod delivers precise 0.05unit doses every time, because my daughter's ISF is 200:1, and 0.05 correction results in a very repeatable 10 point drop in BG. Not sure if all pumps are that accurate, but it's fairly easy to test as long as you have a high ISF.

Extended boluses may indeed be needed when using fast insulin, but in our case, meals always act much faster than humalog (no matter what she eats), so post-prandials routinely exceed the 140 maximum BG seen in non-diabetics. Even if we had to extend meal boluses a little, it will be welcome to at least have the option for a faster response time than Humalog.

For corrections, though, there is probably no benefit to extend. It would be nice to be able to correct for highs without waiting up until 3 AM to see if the correction was enough, too little, or too much.

[Mama Belle]

I can say for certain that the Omnipod delivers precise 0.05unit doses every time, because my daughter's ISF is 200:1, and 0.05 correction results in a very repeatable 10 point drop in BG. Not sure if all pumps are that accurate, but it's fairly easy to test as long as you have a high ISF.



I don't think they are talking about corrections, but rather basal rates. If delivering a basal of 0.05u per hour, that means only a fraction of the 0.05 is delivered every 5 minutes (I think) so that the total amount of basal delivered in that hour equals 0.05u. Delivering 0.05 u all at once is different than delivering it over an hour's time.

[Jacob'sDad]

I can say for certain that the Omnipod delivers precise 0.05unit doses every time, because my daughter's ISF is 200:1, and 0.05 correction results in a very repeatable 10 point drop in BG. Not sure if all pumps are that accurate, but it's fairly easy to test as long as you have a high ISF.


With the Animas 2020 you can actually set a basal rate of .025u per hour and it delivers every three minutes. That means in theory it can give a dose of .00125u. There's just no way it does that every time. I do think the total of all those 3 minute apart doses COULD equal .025u in an hour or maybe .05u in two hours. I just don't think every single dose is super deadly accurate and I think the accuracy of those minute doses would be more important with super fast acting insulin because, like I said before, there is no cushion with super fast acting.

[Darryl]

With the Animas 2020 you can actually set a basal rate of .025u per hour and it delivers every three minutes. That means in theory it can give a dose of .00125u. There's just no way it does that every time. I do think the total of all those 3 minute apart doses COULD equal .025u in an hour or maybe .05u in two hours. I just don't think every single dose is super deadly accurate and I think the accuracy of those minute doses would be more important with super fast acting insulin because, like I said before, there is no cushion with super fast acting.

Thanks mama belle and jacob's dad...

Now I get what you guys are saying. It is true, if basal is only 0.05 per hour, our pump (the omnipod) clicks once per hour and each click is a 0.05 unit increment at that single moment each hour.

That doesn't sound very evenly spread out, but then again I'm not sure it's a problem: During the time of day her basal is 0.05 per hour, if basal was delivered in a single 0.05u increment once per hour, her BG would drop 10 points, then rise 10 points again before the next hour's increment.

So instead of the BG being perfectly flat (which it never is anyway), it might bounce around within a 10-point range. Would that be a problem?

[Jacob'sDad]

So instead of the BG being perfectly flat (which it never is anyway), it might bounce around within a 10-point range. Would that be a problem?

Your probably right. The difference might end up being so minor that it won't be a big deal. I was also just thinking that super fast acting would drastically cut the lag time for basal changes to take affect. That would be a big plus.

I've kind of been flip flopping on this all night.:rolleyes:

[Mama Belle]

Your probably right. The difference might end up being so minor that it won't be a big deal. I was also just thinking that super fast acting would drastically cut the lag time for basal changes to take affect. That would be a big plus.

I've kind of been flip flopping on this all night.:rolleyes:

I just keep thinking about corrections! :D I mean when we have a really stubborn high it takes forever to get her down. Also, think about stomach flu days. You can give teeny bits of insulin that will last for only an hour. You won't run into having all of this IOB with a BG of 80, large ketones and a puking kid!! I dunno I am sure there are pros and cons, but I have been waiting and waiting for faster insulin and this makes me a little bit giddy.

[Darryl]

I just keep thinking about corrections! :D I mean when we have a really stubborn high it takes forever to get her down. Also, think about stomach flu days. You can give teeny bits of insulin that will last for only an hour. You won't run into having all of this IOB with a BG of 80, large ketones and a puking kid!! I dunno I am sure there are pros and cons, but I have been waiting and waiting for faster insulin and this makes me a little bit giddy.

Exactly... If I think about why I am so often up until 3 AM bringing down a high BG one correction at a time, it's because I can't know for certain if the high is due to a brief spike, or a prolonged basal that is 10x the normal basal. So, I give a correction, and it takes 2 hours to know, and meanwhile, her BG is higher than I want it to be for a lot longer than I want it to be.

The cool thing is that this insulin could actually be available a year from now. I hope so.

[Ali]

There was a huge concern with Novolog and Humolog when they first came out. Endos and patients did need to learn to rethink some of their past approaches. I saw years of those concerns starting with the change from using one or two shots of insulin a day to more, then great hesitation with the pump, and the whole basal/bolus approach, concern with home BG testing.The more options we have the better. But new technologies, insulins, medications take time to work with and figure out if "the new" is an improvement.:) Ali

[D A Morisse]

Parents of little ones just imagine... bolusing accurately for meals after they have been eaten and little to no spike at the 1 hour mark

[frizzyrazzy]

I'm sure people had similar concerns about Novolog/Humalog when they came out. As far as i'm concerned, this would be a great step forward esp. for correcting highs.
quite true for highs. It would be amazing.

For food, we'd have to start paying a lot more attention to glycemic index and I am guessing that parents like us would be leading the way in making that information more commonly known. I mean even now, think of how often a nutritionist doesn't "get" carb factoring. So we wouldn't be able to rely solely on medical people knowing how to dose for these foods. It would just a take more work on our part initially.

[twodoor2]

I personally think this will help overalll glucose variablility. I've mentioned that in other threads as well that I believe an ultra-fast insulin would be great for standard deviation. I also think it would also be easier to figure out variable settings.

The one thing about this insulin that I am concerned with is the predictability of it. There is another thread on this forum where the overall feeling is that Apidra is more predictable than Novolog, and I believe that makes a world of difference. I want to give a dose, and if all things are the same, exercise, accurate carbs, stress, etc. . . I don't want that bolus to make the BG fall significantly out of the target range when it is done working. It appears for some, the tail end of Novolog is slightly less predictable than Apidra, and this can cause issues.

My biggest crutch with insulin right now is that fast isn't fast enough, and I really think this will allow diabetics more freedom, and less concerns. And, if you need it, you can always use slower acting as well to cover grazing and foods like pizza. I think regular is the favorite for that.

[badshoe]

Viaject is actually humalog, but with the addition of other ingredients that make it absorb quickly, act in 15 minutes, and be out of your system in about an hour.

I don't think it is humalog I thought it was based on regular. I could be wrong.

Also I don't thing it is said to be that fast. see: http://www.biodel.com/pipeline/viaject.htm That suggest a peak in about 30 minutes and tailing out in the two to three hour range.

I think there would be advantages in kids. Maybe making post meat bolus as effective as pre meal with 'log. Possibly less insulin may be needed. Shorter IOB times


In the interest of full disclosure I have a few shares of Biodel. Like anything else bought in the last year they are under water.

[twodoor2]

I believe viaject is made by the makers of Novolog.

[Darryl]

I don't think it is humalog I thought it was based on regular. I could be wrong.

Also I don't thing it is said to be that fast. see: http://www.biodel.com/pipeline/viaject.htm That suggest a peak in about 30 minutes and tailing out in the two to three hour range.

.

I stand corrected - it is based on regular insulin, not humalog. I only mentioned it because it's not really a new insulin, but some process to make regular insulin absorb very quickly.

From what I see in the graph, though, it does look like it peaks in around 15 minutes, and 80% is out of your system within 2 hours (hard to tell exactly how to interpret the graph), and they state it to be much faster than humalin and humalog.

Thanks for pointing out the typo in my initial post.

[badshoe]

I believe viaject is made by the makers of Novolog.

nope it is made by Biodel