Inhaled insulin for sale in USA by prescription

It’s available. What will the cgm graph look like? Let’s say bolus wizard says to take 4 units to correct a high. Inhale and within 20 minutes the graph drops to normal and levels? Next appointment with Endocrynologist 3/23
Could call and ask for prescription but doc may need to discuss first. But with no patients using it yet there’s not much to discuss. Still won’t hurt to ask.

I called my doctor yesterday and she wants two weeks to study Afrezza. I want to try it. It's activity curve resembles endogenous insulin in a non-diabetic. Many are worried about the dosing increments of 4 and 8 units. I don't think the dosing is unit for unit equivalent to today's rapid acting analog insulin but I'll have to wait to do the experiment. It's getting close.

I did some reading today that claimed Afrezza produced fewer hypos but the FDA would not allow Mannkind to put that on the product label. We shall see.

I have high hopes for this. If it lives up to the hype, this could change the world as we know it…

You’re right the dosing is reportedly not comparable to the dosing of injected insulin-- a lot of people seem to be pretty leery of that idea, but I guess they should be since injectable is all we’ve ever known.

Can’t wait to start hearing feedback on it.

Huh, we agree on almost everything, but apparently not this. Incredibly crude dosing and lung impairment make this totally unappealing to me. As I think Gary Scheiner wrote, I wish the Mannkind guy had invested his resources elsewhere.

Just imagine a world where dosing barely even matters— a “big puff” or a “little puff” being as complicated as it needs to be-- that’s the appeal. Only time will tell if it actually works that way

I think you’re attributing magical properties that are unlikely to manifest. The insulin gets absorbed through the lungs into the bloodstream, how could the dose possibly not matter? X amount of inhaled insulin is still going to lead to Y amount of circulating insulin, and the relationship between insulin and food shouldn’t change. Or am I missing something?

I don’t uderstand how it works either but I do know that even with the crude dosing of 4/8 units it was found to cause less hypoglycemia in trials than the much more highly adjustable rapid acting injectables

The reason the dosing is less critical is because it's cleared from the blood so fast. The normal glucagon regulatory system has time to work -- hypo pressures go away quickly, rather than lingering for hours.

I'm glad this is the last thread where we pit my speculation against yours! For me, I'll soon have the only evidence that matters to me, my n=1 experience.

I have great hopes for Afrezza. I may be disappointed or celebrating performance that exceeds expectations or probably somewhere in between.

We'll next move toward competing judgment on the facts. If the cure ever appears, I'm sure it will be treated with the same level of controversy and debate! There will always be "sides" to take. Look at the measles vax story, an issue that medicine "settled" a generation ago!

Gary Scheiner also believes that the central nervous system requires a minimum of 130 grams of carbohydrates per day!

As far as lung issues go, The FDA sub-panel of respiratory experts made Mannkind go through extra clinical trials to address possible lung impairment. That panel finally gave its approval. Millions of asthma patients regularly deliver medication via this route. I'll take my chances.

I wasn't citing Scheiner as an authority in this case (though trying to discredit him by bringing up an unrelated issue is an odd tactic, you'll notice many thoughtful folks on this forum disagree with him on precisely the issue you raised and yet find him very insightful on other issues), just recalling that I agreed with a post that I think he did on Afrezza.

The lung impairment appears to be modest, so I certainly wouldn't consider it disqualifying. For *me*, together with the super-crude dosing, it makes Afrezza unappealing. For others, possibly including you, not so much. Sharing those differing perspectives is a big part of what makes this forum so great.

The tail in insulin action in rapid-acting injectables does complicate BG control, you basically have to choose between:

1) Matching carb release over the first few hours, and then correcting with a modest carb dose for that long tail (setting a reduced or zero basal rate to match the insulin action tail can substitute partially or wholly for the carb correction), or,

2) Allowing BGs to spike initially, and then be brought back into line eventually by the long insulin action tail.

My sense is most of us on here who shoot for tight control do the former, not the latter (or if it's a spectrum we're more toward the former end of it). That's also why we find the insulin-on-board indicators on our pumps useful, at least after the first two or so hours have passed and the carbs are mostly done raising our BGs. If we did the latter, IOB wouldn't tell us anything useful because insulin would be paired with carb intake such that after five or six hours, BGs would return to baseline.

If one fails to understand, or compensate for, the insulin action tail while pursuing strategy 1, then one will consistently go low several hours after eating. That is undoubtedly one source of lows for those using injectable insulin. But one can also go low simply by miscalibrating one's insulin needs. Personally, I do a little of both.

Afrezza's super-rapid action curve appears very promising, and I would give a lot to have that kind of curve in an injected insulin. (Apidra is a step in that direction, but lacking a buffering agent, prone to occlusions.)

But it's a huge leap to argue that dosing doesn't matter, or even matters much less, because of the super-rapid action curve. Imagine someone said to you that compared to Novolog, with Apidra dosing didn't matter, and you could just do a "really big" injection or a "smaller" injection, units be damned, and you'd be all set, because Apidra had a tighter curve. You'd look at them like they were crazy. That's a bit how the claim that dosing doesn't matter for Afrezza makes me feel.

please report your trial…best post!

And that makes sense--some lows for folks on current injectable rapid-acting insulins are caused by people failing to understand, or to compensate for, the long insulin action tail. But other lows are caused by simply miscalibrating one's insulin needs, especially when these are variable (i.e. I:C ratios fluctuate both based on various other factors and stochastically, too).

For a sophisticated user with a varied diet, the super-crude dosing seems like a huge handicap to me--there's a reason so many of us celebrate our pumps' ability to do such fine-grained dosing. But if you're willing to eat to your dose, the lack of a long tail is a huge benefit of Afrezza, and perhaps even worth having to eat to a crude dose and the apparent modest lung impairment.

Agreed, it'll be great to get actual experience, and I'm looking forward to hearing back from you and others. Based on all the information we have from clinical trials, I think I have a pretty good sense of how Afrezza will work in the wild, but I'm definitely open to being surprised.

I actually have a vague recollection there is some interesting research on insulins that are less dose-dependent, they sort of float around in the blood stream inactive and only get activated in the presence of higher glucose levels. But I may be thinking of some implantable options that have a similar dynamic. That stuff's all much farther down the road, though.

Sorry, my earlier reply was unnecessarily provocative.

You're right, you didn't bring up Gary Scheiner as an expert, just an expressed opinion.

I am also in the crowd that respects Gary's expertise. In fact, he's helped me directly. We should, however, treat any opinion expressed by opinion leaders as just that, the opinion of just one person.

We shall see if the "super-crude dosing" criticism has any merit. I've written many times about the Afrezza trial user that didn't find that an impediment, at all. He posted here for a few days before he gave up in the face of staunch challenges and disappeared. I have read reports from other apparently reliable sources that say that incidence of hypos with Afrezza are much better than injected insulin.

No worries, easy to get carried away in the heat of the moment, all the more via the anonymity of our computers. I've found your contributions to be really valuable and have enjoyed our interactions, and plan to continue to do so!

I'm fascinated by what you mention about the Afrezza trial user. As I've written all over this thread, lower incidence of hypos is exactly what I would expect, based on my understanding of Afrezza, and doesn't, in its own right, make the case for dosing not mattering. Dosing might *also* not matter so much, but I'd want to see evidence of that directly.

For example, did the trial user report that dosing just didn't matter so much? So he could consume 40 grams of carbs one meal, and 70 grams of carbs another, and the Afrezza 4 unit dose seemed to match both pretty well?

If, somehow, the CGM curve on those two meals looked about the same, that would suggest that something other than Afrezza's super-rapid action was going on, and Afrezza was somehow self-calibrating its response to BGs. Nothing I've seen suggests to me Afrezza has this property, but it would be amazing if it did, and I'm under the impression there's research ongoing to try to develop just such treatment options.

When you try Afrezza, I suspect you will need to make an effort to eat to your dose. Given the lack of tail, I would expect it to be a bit more forgiving of a mismatch between dose and carbs, but not much. But I could be wrong, and if so, it'll be interesting to try to explain why I'm wrong, i.e. what properties Afrezza has that allow it to act in this way.

I've tried to find the thread in question but I think it was a few years back and appears to dropped off the archive horizon. Working from memory, he did calibrate his dose with his food and experience. He was challenged very pointedly by many here about dosing in 4 and 8 unit increments. They couldn't imagine how those fixed doses would work for them. The trial user didn't seem to think this was a problem. The only conclusion that I could draw was that this insulin worked differently.

If I have to eat to my dose and that leads to eating more than I want, that would be a big negative for me. I've dropped my TDD down to 28 units recently and lost some weight. I don't want to reverse that trend.

Sounds like he was eating to his insulin, within the constraints of the 4 and 8 unit options. Especially for meals, that doesn't have to be super onerous, and especially for those on moderate rather than low-carb diets.

For snacking, or for lower-carb diets, or for more varied diets, or for correction doses, having tasted the freedom of granular pump dosing, I'd hesitate to go back to even half-unit kiddie pen dosing, much less being stuck with four-unit increments.

But the super-fast action curve does sound nice. And I don't see any inherent reason why the doses can't get somewhat smaller, in fact I believe that's in the works.

No, no, dosing does matter, of course!

It's just that hysteresis and the variability in tissue response to insulin due to a number of factors (BG level being one of them -- ever notice how you seem to gain some IR at high BG?) makes dosing for ultrarapid acting insulin much more "squishy". Of course one can overdose and go hypo, or underdose and fail to clear all the glucose. However, because of the dynamics of the BG control system, there is a range of dosing that will work, and the faster the insulin clears, the wider that range gets due to the body's ability to be more effective with counter-regulation.