The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm
Let the comments begin:
I intend to follow Afrezza developments closely now that it's been FDA approved. The FDA approval does contain a "black box" warning for people with asthma or chronic obstructive pulmonary disease.
Afrezza's fast onset, peak (14 minutes!), and duration are more like the glucose metabolism of a non-diabetic. I'll be curious to see if Mannkind (the company that makes Afrezza) gets the partner it needs to bring to product to market. I read earlier that it would take at least a year before it will be available to PWDs.
We may have another useful tool in our kit soon.
I am very interested in Afrezza. I have no lung problems and would welcome a quick, really fast acting correction.
We've had several discussions about this before and the thing I keep getting hung up on is the dosing. It only comes in 2 or 3 set doses and they were fairly high for a Type 1. I can't remember the number (and you had to translate it as they aren't the same as injectible units), but it was something like 3, 5 and 7 units. The three might be useful for me when I'm significantly higher than I want. But even if they made a 1 and 2 unit dose it's still very imprecise. In going from MDI to pumps, most of us saw the advantages in being able to bolus 1.35 when that is what your computation called for rather than 1 unit (too little) or 2 units (too much).
Hi Zoe, I have never, ever needed a 3 or 5! A one would be useful, and I've been on MDI long enough that I don't worry very much about precision. I dose differently from most people with pens--I use a 1/2 dose BD syringe to withdraw insulin from both my Apidra and Levemir pens (rather than a pen needle), but w/o a pump, I don't expect any more precision than that.
But my understanding is as of now they are not proposing anything like a 1 unit dose, so the doses would be virtually useless to you and many others. I could occasionally use 3 units - I have an ISF of 1:45 , so if I was 250 I could use 3, but I'm not even positive there is a 3 unit dose. Maybe someone who is more enthusiastic about the product can clarify that. Last time we discussed it, for some reason people didn't seem to see the dosage issue (at least for Type 1's) as as significant as I do.
My takeaway from the person that posted here, an Afrezza trial participant, was that the dosing acted differently than injected insulin. He wrote several times that he had very little hypoglycemia. He also wrote that he could rapidly bring down high blood sugar.
I look forward to trying it myself. I'm concerned with the long term effects on my lungs but I'll have to wait and see.
I have to assume that after the years and years of FDA trials and tribulations… They probably looked into the dosing amounts and determined that it seems to work
This is exactly what I need as post meal highs over 200 (that don’t linger more than a couple hours) are my only problem right now. I wouldn’t use it when eating low carb meals, i.e. <30 grams, but it would be great to have a fast acting first phase stand-in insulin when I do eat higher carb meals. Any official word on how long before it is available?
My thought, too, Sam.
I feel like I'd try this if I could get just a sample of it, but not for long term use. The smallest dose is 4 units, which would be perfect for any meal after breakfast for me , I eat a lot of meals that require 4 units of insulin. It sounds like it'd be awesome for when I go out to eat and I'd get a good idea of what it was like for a meal that requires 4 units to talk about it lol.
Good article explaining the mechanism of action and dosing differences between Afrezza and injected rapid acting insulins:
http://seekingalpha.com/article/2293035-mannkind-what-the-afrezza-label-really-says
I'd love to get questions for a call with MannKind on Afrezza. Suggest topics, ask questions and enjoy the YouTube recap on the Allie's Voice About Diabetes e-newsletter. Subscribe at www.alliesvoice.com
Is there a version of the article out there that doesn't require you to register with an investment site anxious to fill my mailbox with pitch after pitch?
Wow. Wow. Maybe it could be sniffed anytime BG goes out of range. The faster insulin was the biggest single step forward.
When I emailed the web address to myself it doesn’t ask you to register to get the second half for some reason, but here’s the section explaining dosing:
“Much has been made of the fact that the data published in the label suggests that Afrezza does not lower blood sugar as well as injected insulins. To those who understand what the activity curve graphs included in the label imply, it should be clear that MannKind’s explanation given during the ADCOM for this lack of superior performance – that Afrezza was not dosed optimally during these studies, due to physician caution – is likely to be correct.
The activity curves published with the label make it clear that Afrezza starts working at the same time that injected insulin does, roughly 53 minutes after it is inhaled, but unlike the injected insulins, Afrezza exercises its strongest impact on blood sugars when it first becomes active, and then immediately starts fading out.
This is very different from how injected insulins work. The injected insulins start working at that same 53 minutes, but then continue to work even more strongly for the following hour or two. This means that injected insulin is often working long after the glucose from a meal has been disposed of. When that happens, people have nasty, dangerous hypos.
This is why when injecting fast-acting insulin, the dose must be low enough that the amount that becomes active at that 53-minute time period is lower than what is needed to completely dispose of all the glucose released by the meal in the first hour, during which most digestion takes place. With Afrezza, however, because it stops working so quickly and is out of the body so quickly, it should be safe to use a much larger dose, which would result in a much more normal blood sugar at 1 hour after eating – the time when blood sugars are most likely to be dangerously high…This difference in how the two insulins work make it impossible to use a straight one-to-one dose equivalence table when prescribing Afrezza, though the label provides such a table.”
Very interesting. Of course this may work for a baked potato but for those of us who eat meals that digest slowly - high fat, high fiber, mostly protein, etc. - and use dual waves or tiered shots the very rapid action is likely to be very unsatisfactory.
Re: dosing
Don't remember where I read saw this (or even if I did :-)) but it's itching in the back of my memory so...
I think the initial target market for this is T2s. Chiefly because precision dosing with high resolution isn't possible yet with the current delivery system and absorption dynamics.
As a result, they are going after T2s with insulin resistance that don't need such fine resolution to dosing (U increments are not a problem), and as a means to control postprandial BG for such people.
I'm very excited about it. I'm going to give it a try as soon as it's available, and if it works well for me, I can leave the pump behind and just treat my "asthma" before meals.
Lilli, on a tangent, I've had great success with tuning pre-bolus timing and combination boluses to get the postprandial down. I used to zoom over 200 routinely after eating, despite covering the carbs with insulin.
Have you put some intensive work into fine-tuning and nuancing your bolus administration?
These days, if I do it right, I can eat a 40g carb lunch with 40g of protein, and never go over 140 (or only a smidgen). Entire period of the postprandial "hump" is 2 1/2 - 3 hours.
When I don't mind my P's and Q's, I can eat exactly the same thing and fly up to 220.
My keys to making it work: