That person at the FDA went to jail for 20 years this year. I am a 230 lb guy and very fit. I used to use about 10-15 units of Novolog or Humolog per meal.
Now I use about 70 to 90 units of Afrezza per day. Keep in mind it is not comparing apples to apples.
It will be early 2014 before it it comes before the fda again. This is estimated by Mannkind. The last trial patient will make their last follow visit in May and they have to get the data ready and reapply in July/AUG/Sept of next year. FDA takes 6 months to reveiw. The FDA HAS been working very closely with the company on designing the current trials..In fact the FDA asked for trials on type 2 as well. This is what the FDA ASKED FOR NOT THE COMPANY. So we shall see what happens.
I can tell you this Afrezza works better than ever imagined. I never expected to be doing se well with managing diabetes. I have lowered my A1C into the 6s in a few months.
It seems as if it's like apples and oranges? My main concern with something that's not as "sensitive" (???) is that it might be hard to match the precision of a pump. Although the wikipedia page suggests that it doesn't crash you out if there's leftovers? That would be awesome! I'd try some. I could just keep my pump for basal and try some of that stuff for boluses, although I'm sure there'd be an insurance issue with something like that.
Not every medication is for everyone. As I mentioned my a1c is the 6s from 8s in 4 months. There have been 500 patients on the trials and the dosing is only for the trials which have worked out well. Yes I agree that they should have a 5 unit cart which would equally to 2-3 unit of normal insulin. I have had o severe lows in 4 months so there is no need to feed the insulin. The inhaled insulin mimics the bodies normal response to meals. It does not work like normal insulin. I have had high and lows for years on humolog and novolog and so do my friends. That has ended 4 months ago for myself. Only 30% of type 1s are on a pump so if you are used to the pump and do not experience lows and do not worry about night time lows perhaps this is not for you. . I am a patient who has had life reversing dramatic results and I am here to share my story. This medication might be pointless to you but it wont be for 1000s of others just like the insulin pump was pointless and all big pharma gave up on it accept Alfred Mann....Please review the story of the insulin pump..
Only 30% of type 1s are on the insulin pump..The pump was never for me.. Afrezza does not crash. It sounds like you have things under control. The difference is the onset is the same as the bodies normal response and there is no lingering insulin left for hours. Not everything is everyone. I am not here to say one way is better than another way. I am here to reach out to those that are tired of insulin lingering for 3-5 hours and have had too many close calls. With Afrezza I can just eat and measure my blood sugar one hour after a meal and correct it in 30 minutes with most of the insulin out of my system in another 30 minutes. This still beats humolog and novolog unless I take it well before eating and it onsets much later and lingers for 3-4 hours. What I am saying is for myself I found something much better that works for me and it will help many others as well.
I do find it interesting as JohnG whose posts are always very level headed said that the researcher at Afrezza went to prison, and then "Afrezza User" translated that to "the person at the FDA went to jail". Maybe Spock is right. Whenever someone ignores evidence, and questions and goes on happily praising something it's either spam or the D version of a cult.
Not a researcher at Afrezza. A researcher at the FDA who was convicted of insider trading of over 20 companies. JohnG never said a researcher at Afrezza. The FDA asked for another trial. The FDA wants to have nothing to do with it. Please tell me why they asked for the trial to expend to type diabetics from type 1s and to children as young as 4 years old. I did not translate anything as....you posted. Yes I am praising it because I am on it and have lowered my A1Cs to almost a non diabetic levels... I think that speaks for itself. Here is the link for you so you can get up to date info on this http://www.forbes.com/sites/billsinger/2011/12/01/updateformer-fda-chemist-named-in-insider-trading-cases/
TChang Yi Liang, a chemist at the FDA with access to the FDA intranet, noted the imminent approval and purchased 18,000 shares of MannKind at $8.41 per share. It has been learned that Mr. Liang had a history of improperly using confidential FDA information for personal gain.
The FDA responded buy asking for two more study's...;-(
I'm glad you have posted your experience. I'm curious do you ever have to take several doses to cover slower-digesting meals? Surely your meals digest longer than 30-40 minutes when 90% of the Afrezza has already metabolized?
I have allergies and asthma and personally wouldn't want to be inhaling powder into my lungs!
I do think an ultra rapid insulin is needed, but don't understand the big deal with injected/pumped versus inhaled. I haven't yet met a single diabetic who minds injections or a pump. To me it doesn't make sense to inhale anything other than medication that is targeting the lungs in some way.
I also think it would be too fast for a lot of meals. I think an ultra rapid insulin in a pump would be perfect, except of course it would increase the risk of DKA in case of an interruption in delivery, which I personally would accept.
Correct. Also for those that do have nigh time issues it would be a good tool for correcting blood sugars before bed. I almost went into a coma from a night time low. As far as the few posts about asthma users as I mentioned not every medication is one for all. I am just saying as a type 1 diabetic for 10 years this has done me wonders. I been through a million tests including lung tests and blood tests and it has never looked better. My lung function is the same as before...Safety has already been proven as many of the Exubera users have been on this for 5 years when they got compassion use permit from the FDA when it was discontinued.
Well 10% i would say sticks around for another 1 hour. Once in a while yes it does happen but it takes me only 25to 35 min min to correct it. You can do that with no crashes... Someone above posted about inhaling something into the lungs. I think its more normal to inhale insulin which is in the body anyways vs all the smog we inhale all day. There have been patients on this for 5 years with 0 safety issues. Until I went on the trial it is hard to believe what Afrezza does till I got to experience it myself. You could actually not even take Adfrezza at the meal but eat first knowing that you can adjust your insulin from any level in 30 minutes which would still be better than Novolog and Humolog from my experience. It seems many posters here have perfect control on the insulin pump. The people I know all have highs and lows and crashes but many here indicate they do not. 1 in 20 die of low blood sugar so its a big problem. That is way too high. Think about it if you eat and take your novolog your blood sugar spikes right away where as with Afrezza it really limits your spikes. It also takes a few week to get a hold of how works on your body and figure out the titration just like with any new treatment.
AfreezaUser -- Thank you for posting your experience with this ultrarapid inhaled insulin. It's short duration is an especially appealing feature. I will be watching for this to get through the FDA and come to market.
This sounds pretty exciting to me... as does any true Ultra rapid insulin (injected, inhaled or otherwise). My onset time for Novolog/rapid is up to three hours, and remains in my system for up to 6 hours, and is very variable, a ultra rapid acting insulin would be a life changer for me. Thanks for sharing this information, it's something I look forward to following. Nice to hear that Afrezza has been such a good thing for you.
I did a study for exhubera study for 2 years. i had no trouble with the action of the insulin or the size of the inhaler( which was large, but more like the size of a meter) the trouble with it was the size of the insulin caps. you had your choice between a 10 unit and a 3 unit cap. It was not possible for me to correct slightly high sugars. this caused my a1cs to go up. Secondly the power is an irritant and often i would cough in the middle of inhaling and have no idea how much insulin I took. And When I had a cold I had to go off the inhaled insulin all together.
the kicker though is that most of the people in the study had a decrease in lung volume and capacity. Mine has recovered though but it took years.
The thing that i worry about most is that you are in violation of the study protocols by posting here. You are not permitted to talk to anyone, nor post on a website about any product that has not been approved. you are setting yourself up to be sued and you could invalidate the results of the study this way.
I know they warned you about this because the make you sign the standard form prohibiting it.
You have to know why, if other on the product read this, then they may falsely develop the same side effects that you have or lack of. Also you are undermining the companies right to keep the results private until they are ready to release them.
I would stop posting if i were you, but really to me it sounds like you are selling something.
No problem Zoe...I am here to share my experience and I know it might help others as well. I am in a occult..I am part of a trial under a very well respected Doc in the USA.
Now days it takes sometimes 3 runs to the FDA to get things approved. In fact there are many other diabetic treatments and devices that crawl under the FDA guidelines. We are all hurt by the gridlock of the FDA. Its a story that is way more complicated than someone making a off the cuff remark that the FDA wants nothing to do with it.
Thanks for the input, Timothy; that was the main question I had, how can you accurately manage blood sugar with only two choices in dose. The OP never responded to that question.
I think Spock had it right from the beginning; it does sound like SPAM which is against the TOS of this website. It's always a dead giveaway when you see a person who has only made one post.
I think there would be a place for this even in someone who was very well controlled on a pump. I don't normally need to bolus as much as five units for a meal, but I can't commit to never eating carbs again, so it may happen. And I think it would be great for corrections. I need five units to bring me down from 250, and that is not unheard of for me. And I do like the idea of something so quick acting if you need a big bolus close to bedtime. I sure hope they figure out how to make it in one unit increments. Smaller would be nice, but you could always do 2 units of Afrezza and .3 units through your pump.
It seems like a lot or all of the type I's in the trial must be using both Afrezza and normal insulin. It couldn't be that there are many people who can live with only five unit increments.
