Last week I attended a diabetes education meeting where I was introduced to Afrezza by an endocrinologist using it with many of his patients. If you don’t know, Afrezza is the new inhaled insulin from Sanofi. It’s not quite yet ready for primetime with consumers, but it’s making the rounds with health care providers. At my meeting there were three Sanofi reps, two doctors, one nurse and me.
Afrezza’s benefits are largely that it takes away the fear of needles for type 2s. But I like the idea that it works faster than today’s rapid-acting insulins so one doesn’t have the typical after-meal blood sugar spikes. Faster in, faster out.
I arrived at the meeting with great curiosity – I’ve been reading about people really liking Afrezza, including type 1s like Amy Tenderich above, who wrote a fantastically informed post about trying it herself on her blog here – and I came with two concerns.
At the meeting one of my concerns went away, yet I don’t know how they do this. As a type 1 who eats a very low carb diet I use very little mealtime insulin. 1 unit is typically my coverage for a meal any time of day other than early morning when I’m experiencing the Dawn Phenomena. Thus, I couldn’t figure out how Afrezza – where the lowest dose is 4 units – and I could ever be compatible. I still can’t make sense of the answer, but I learned that you don’t calculate it as in a 1:1 conversion. If you use anything less than 4 units of rapid-acting insulin, you take one blister pack (a 4 unit dose) of Afrezza. Math is obviously done differently in the pharma world.
However, my other concern lingers. For some reason I heard at the meeting that Afrezza has been in clinical trials for two years* (Many have corrected me, see below. The rep just sent me the package insert which may explain the two year period. I’ve put it under ‘Comments’). While Afrezza shows no particular strong influence of harming the lungs, currently it’s not recommended if you’re a smoker or do have any lung issues. Many people experience a cough, some lose it, some don’t. To start Afrezza, you need to first have a lung function test.
As for that pharma math, I’m about to give Toujeo, the new basal insulin, a test drive. A CDE friend gave me a sample. Toujeo is a concentration of insulin three times greater than Lantus and Levemir, so you can’t do a 1:1 comparison here either. Thus the warning, don’t attempt to extract it out of its pen with a syringe.
All in all, I’ll wait a few more years to watch whether Afrezza does impact lung function. In addition, I wouldn’t want to change two variables – Touneo and Afrezza – at once when it comes to my diabetes management. It would be too hard to know which is causing what.
But it is an odd thought that after a decade of using Lantus and Humalog, that have become like old friends, in a few years I may throw them over for two completely different BFFs.
* Readers let me know what I heard at the meeting was incorrect regards Afrezza’s length of time spent in trials. See comments.
10 thoughts on “Afrezza has some strong support”
Your comment – “Afrezza has been in clinical trials for only two years. It shows no particular strong influence of harming the lungs.”
Afrezza has been in multiple trials for a decade and no lung issues have been noted. 2 years? Not even close.
Mannkind has spent 2.5 Billion USD over 10+ years doing several trials involving thousands of patients, across several continents. I wish you were better informed. There are patients who have been using Afrezza continuously for 10 years. Some Exubera patients were transitioned to Afrezza. Afrezza is just FDKP salt + Insulin. The FDKP salt is not metabolized and excreted.
There is so much material available on this safety issue.
In addition to trials conducted to better understand TI dosing, short-term safety and efficacy,
and device utility, 10 Phase 3 efficacy and safety trials were conducted earlier in the course
of TI development (Appendix 3); 4 of these had a treatment duration of 16 weeks or longer:
2 trials in subjects with T1DM (Trials 009 and 117) and 2 trials in subjects with T2DM
(Trials 102 and 014).
Question is, what is worse? Long term complications of uncontrolled Diabetes that is sure to occur or unknown lung cancer threat?
Well that’s interesting Brian, because the endo said two years. Can you point to the data? I’d love to know.
Jon, thanks for the info. You’re right, I was in this instance going by what the endo presented. Perhaps he was referring to something else regarding the two years of trial. Glad to know you have provided this info.
A good place to go is FDA briefing document.
Click to access ucm390865.pdf
particularly page 64.
While I was wrong on the trial period, thank you everyone, guess i wasn’t wrong on the strong support. More evidence of long-term safety testing from Vish – and funnily enough Amy. This from 2009: http://www.healthline.com/diabetesmine/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann#1
There are Exubera patients who switched to Afrezza about 6 years ago on a compassion use basis using the old inhaler. Sadly, the FDA denied my compassion use application when my trials were over 2.5 year ago.
I was on Afrezza for 6 months on my trial and another 4 months since it was launched in January. For me, Afrezza has been a cure. I am a type 1 and I live like a non-diabetic. Thank you for the positive article.
This may be where the two years of study comes in. In the Afrezza package insert it says:
5.4 Decline in Pulmonary Function
AFREZZA causes a decline in lung function over time as measured by FEV1. In clinical trials excluding patients with chronic lung disease and lasting up to 2 years, AFREZZA-treated patients experienced a small [40 mL (95% CI: -80, -1)] but greater FEV1 decline than comparator-treated patients. The FEV1 decline was noted within the first 3 months, and persisted for the entire duration of therapy (up to 2 years of observation). In this population, the annual rate of FEV1 decline did not appear to worsen with increased duration of use. The effects of AFREZZA on pulmonary function for treatment duration longer than 2 years has not been established. There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of AFREZZA. The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes.
Let’s forget the cancer scare for a moment, even injectable insulin comes with side effects and risks; after all, man-made insulin is a drug, and not a naturally occurring hormone! Less is more, in this case; personally, I eat very low carb (only raw fruit and veggies, limited meat in the form of roasted chicken breast and boiled eggs, no dairy and absolutely NO processed and preserved foods) and my A1c went from a whopping 11% (on the ADA recommended diet) to 6% the way I eat now. But, the interesting thing here is, by cutting out all processed and preserved foods, not only was I able to but my A1c down in half, but…
…I was also able to cut in half my NPH (intermediate-acting insulin) and I am now using absolutely NO fast-acting insulin either with meals or to correct! Unlike you, I’m not worried what a 4-unit cartridge of Afrezza might do to me, now that I’m not taking fast-acting insulin, anymore. There’s just no need to take it, in the first place!
What I’m concerned with is…
…what everyone is eating that requires them to take so much fast-acting insulin, in the first place! The thing is, good overall health is just as important as controlling blood sugar (if not more!) because it serves as a foundation for everything else. And when Afrezza users like Sam Finta claim Afrezza lets them eat like non-diabetics, it worries me. I’m happy for Sam he’s making strides in his diabetes management; but I’m worried what “eating like a non-diabetic” might do to his overall health.
From the tweets he posts about what Afrezza is letting him eat (pizza, donuts and Girl Scout cookies), I’m worried Afrezza is letting him eat bad food, even if it is controlling his blood sugar. What’s the point of controlling your blood sugar and minimizing diabetes related complications if pigging out might end in a heart attack?
I’ve done all the research — and according to a recent study, eating foods high in fructose (processed, not natural fructose found in fruit), leads to metabolic syndrome and can give you a heart attack. I don’t know why it took scientists so long to figure that out, but it’s finally been proven. Here’s a link to the study: http://www.nature.com/nature/journal/vaop/ncurrent/full/nature14508.html and here’s a link to the news article: http://www.eurekalert.org/pub_releases/2015-06/ez-fpa061715.php .
I’m also wondering what it was Sam and other Afrezza users were eating before the trials that made it so hard for them to control their blood sugar, to being with. Anyone who counts carbs and eats a healthful diet can easily control his blood sugar with just enough background insulin and very little basal insulin. You’re a testimony to that, Riva! You only take 1 unit of Humalog with meals. I take 0 ! We’re neck and neck!
You know what happens to people who “eat like non-diabetics?” They get diabetes. The trick isn’t to figure out how much Afrezza you need to cover a meal; the trick is to find a way to eat a healthful diet without needing so much insulin…period. Blood sugar is only one small piece of the puzzle. What about your overall health? Why don’t Afrezza users ever speak of overall health?
Sam Finta once said, “Some day there will be millions and millions of Afrezza users.” That’s a scary thought, if you ask me! Wouldn’t it be something if everyone learned how to eat right and exercise so that some day…
…there won’t be any more diabetics?
That would put a dent in Al Mann’s wallet!
You don’t have to publish my comment, Riva. It gives me enough pleasure just knowing you read it. And thanks for listening.
Pingback: Sam Finta says, ‘Someday there will be millions and millions of Afrezza users’ and THAT scares me because…