Saturday, February 27, 2010

Afrezza meets the unmet medical need of diabetics

Link

Value of early intervention

Link
Diabetes & Vascular Disease Research
6(4) 283–
287
© The Author(s) 2009
Reprints and permission: http://www.
sagepub.co.uk/journalsPermission.nav
DOI: 10.1177/1479164109341691
http://dvr.sagepub.com

What are the practical implications
for treating diabetes in light of recent
evidence? Updated recommendations
from the Global Partnership for Effective
Diabetes Management
Clifford J. Bailey,1 Lawrence Blonde,2 Stefano Del Prato,3
Lawrence A. Leiter,4 Richard Nesto,5 on behalf of the Global
Partnership for Effective Diabetes Management*



It is possible that the failure to demonstrate a benefit of a
lower glycaemic target on macrovascular outcomes in
ACCORD, ADVANCE and VADT was due to the fact that the
intensive glycaemia treatment was implemented at a relatively
late stage of the disease and that earlier and more prolonged
intensive treatment would have proven to be beneficial. This
is supported by recent data from the extended UKPDS glycaemic
follow-up, which indicated a significant reduction in MI
and overall mortality, as well as microvascular complications,
in those subjects originally assigned to the intensive versus
conventional glycaemic control group.14 This may be
explained by a ‘legacy effect’ in that early risk reductions
persist over time and, in the case of macrovascular risk reduction,
may take many years to manifest.8 Of note, in addition to
the much greater duration of follow-up in the UKPDS
(median 17.8 years), patients were newly diagnosed at the
time of enrolment. Therefore, UKPDS patients were at a
much earlier stage of the disease course compared with those
in ACCORD, ADVANCE and VADT, with a mean age of
53 years at baseline compared with 62, 66 or 60 years, respectively.
Furthermore, a prespecified subgroup analysis of the
ACCORD trial which showed greater reductions in the primary
(cardiovascular) outcome in those subjects with no prior
CVD and in those with a baseline HbA
1c
< 8% is also consistent
with the hypothesis that earlier glycaemic intervention is
more likely to be associated with cardiovascular benefit.
These findings add further weight to the data supporting
early
and effective intervention to achieve good glycaemic control,
which have been reviewed previously.12,15–17

Tuesday, February 23, 2010

Feedback from real Exubera users

I could have spend more time, but the message is loud and clear. Most of Exubera users loved the product and were angry when the product got pulled.


1) (From diabetesforums,)
12-04-2004, 07:16 PM; by Andrea; (not clear what device she used)
I was on inhaled insulin for 6 months in a clinical trial. That was 4 years ago and i asked my endo to get out of the trial and go on the pump. The inhaled insulin worked, but i wanted something that was more precise in terms of insulin doses. During the trial i took one shot of Ultralente per day and inhaled at meals.

As for lung function, mine stayed the same over the 6 months, but i found that my throat or vocal coards were affected a bit. I would loose my voice regularly for short periods. But there were no tests for that.

The only advantage that i could find with inhaled insulin was less actual injections. But i think most of us who take insulin would agree that the actual injections are not the most difficult part of having diabetes. It has definite advantages though, for people who are needle phobic and those who don't need very precise doses of insulin at meal times.
-------------------------
2) From http://www.diabetesmine.com/2007/01/followup_with_a.html
Editor’s Note: Oooh, this post is so TIMELY, in light of the fact that the LA Times ran a front-of-the-business-section story on widespread doubts about inhaled insulin this weekend. Our gal feels differently. Read on.
Back in October, DiabetesMine.com spoke with Jennifer Haws of Des Moines, IA, pioneer in the use of new inhaled insulin from Pfizer. I made her promise that she’d give us an update after three months, so we could discover if she remained as exuberant about Exubera as she was at the outset. Well so far, so good. Jen now says “I still think that I am the only person in the world on it and it’s so great!”
So here’s our latest little chat about inhaling vs. injecting and any concerns that might come with it:
DM) Jen, are you still feeling as positive about the Exubera inhaled insulin experience after three months of use?
JH) I sure am. This has been such a great advancement in diabetes management. It is working great and I love it!
DM) What about results? How has Exubera affected your mean blood glucose readings and your A1c?
JH) My last A1c was in December and it went down to a 6.7!! Exubera controls the spikes. When I was on shots, I would roller coaster up and down and it would just make me feel horrible. Since starting Exubera, I have not had one day that this has happened. Of course I have had lows and some highs, but no I’m no longer and jumping all around with my numbers.
DM) Any lessons learned? Drawbacks? Or tips and tricks to share with other users?
JH) I have learned that the recommended two-week replacement of the cartridge inside (the filter-like thing) actually works better at a one-week replacement with cleaning. If not, at the end of the two weeks, it seems not to dose as well and gives me higher numbers. So far, no drawbacks. I did get a case for the unit which holds the inhaler and my tester, so that makes carrying very nice.
DM) And socially? Are you still comfortable carrying and using the relatively large Exubera inhaler device in public?
JH) Ah…it’s a breeze! I get it out in public, take my dose and am usually done before anyone even notices. If by chance they do, I am more than happy to tell them what it is! Most people figure it for something to do with asthma, so they don’t usually bat an eye.
DM) Any concerns about long-term lung damage? (What does your doctor say about this?)
JH) I don’t really have too much concern for this. My doctor had me do the regular breathing test required before prescribing. I know that all meds have some sort of side effect or drawback, but so far I have not noticed any change or difficulty. Being able to manage my diabetes so easily and limiting or removing THOSE complications weighs higher as a concern for me.
DM) Lots of people write to me looking for insights on whether they should try inhaled insulin. What would you say to these potential users?
JH) GO FOR IT! As someone who has been on pills, shots, restricted diets……and NOTHING worked for a long-term solution, I would say, TRY THIS! Exubera makes a WORLD of difference. Diabetes is a demon that takes so much of your life to control, having something so simple is an absolute godsend. It makes me feel like I CAN BEAT THIS!
Thanks , Jen, for sharing your enthusiasm. I personally would like another reality check in three more months, because as I learned with my DexCom, there does seem to be sort of a honeymoon effect with new devices: you love them until they become as commonplace and annoying as the older stuff. Let’s hope to ping Jen again down the road just to be sure

3) http://blogs.wsj.com/health/2008/09/16/inhaled-insulin-gasps-for-breath/tab/comments/
    • 5:45 pm September 19, 2008
    • Terrie wrote:
This is from the wife of a diabetic who is needle phobic. Exubera was a godsend in helping him control his blood sugar level and freeing me from never being far from him to give him a shot. It gave him his freedom and dignity back. No Exubera isn’t perfect but no insulin delivery system will work well if the patient doesn’t actively manage the illness with diet and exercise. All you people can talk about possible side effects and money made or lost all you want but I hope every one of you loses someone you love or has their life destroyed because a drug isn’t available because of profit or business politics.
    • 3:55 pm November 7, 2008
    • Carol wrote:
I was on Exhubera for a year and a half and only now am I just about out of all my supplies. Having medicine so that I only had to take 1 needle and day rather than 4-5 a day is a fantastic improvement and I did not have any problems with my lungs! I only hope and pray that a new inhalled insulin is available soon. I don’t have any idea what I will do until then. I think Exhubera went south because of poor advertising!!!I only saw 2 ads for it in the first 9 mos I took it–versus about 4 a day for viagara!!!! What a waste to drop Exhubera. I hope Mannkind’s inhalled insulin works and is out soon!!!!
·
    • 4:05 am February 16, 2009
    • MMRNTYPE1 wrote:
I was a rep for exubera, and used it for my type 1 diabetes. it was wonderful, and i didn’t mind the device. what i found was that physicians didn’t want to prescribe it because they had to learn a new way of managing their patients, and they just didn’t have the time or motivtion. they stated that their patients just didn’t mind giving shots. they obviously did not speak openly and honestly with their patients. even if the drug increases my risk for lung ca, i would still use it. i had much better control of my diabetes with one shot a day on lantus, and being able to carry the powdered inhaled drug with me in the hot car, or freezing temps. i would whip it out in an airport, resturaunt, etc and inahle and it was over. i have been diabetic for 35 years, and this is the first new product for us in that length of time. i hate hearing about how it isn’t difficult to give shots. it is a pain, and i don’t do it as much as i would give my exubera. my diabetes is much more out of control now. i have many more hypoglycemic episodes, and my life feels more out of my control. i only hope and pray that this new form of inhaled insulin comes on the market before i die. i was so happy on the exubera. it was the physicians that i spoke to who complained that it was too big, too hard to use, not the patients. i was so happy not to be covered in bruises all the time. physicians and researchers just don’t know what it is like to live with this disease. i wish money was not involved, or exubera would still be on the market. the government should get involved to support a drug like this. exubera failed because they didn’t promote it for the first year after it was released. then when they finally hired educators to teach medical professionals about the inhaler and how to dose the drug, they were 80 to 90 percent more likely to prescribe it. however, their time is so short with patients, they didn’t bring up the new delivery system because they didn’t have the time. the patient had to bring it up. it was an awful marketing mess up on the part of pfizer. their reps weren’t talking about it because they weren’t getting paid a large enough commission even after deciding maybe they should start marketing the thing. they put six months into marketing it, then stopped production, and the very next day bought a small company with a promising pipeline. pfizer is in trouble because of their pipeling, and diabetics are the ones to lose out because of their mistakes. the lung studies were not worrisom, and the fda approved it with simple lung function tests that could be done in office. the drug failed due to business reasons and a mismanagement of their marketing department, not because the drug was not safe or desired by patients. it is nonsense that patients didn’t like it, it was the nondiabetic physicians that complained about the size of the delivery device, not the patients. it was the physicians who don’t have to give four to five shots a day that said it was easier to give shots. i am angry and wish i could go to europe where there is supposedly inhaled insulin available. god damn america for it’s lack of compassion for patients who depend upon large and small pharma companies for their very lives.

 

 4) http://www.diabetesselfmanagement.com/Blog/Tara-Dairman/exubera_inhaled_insulin_discontinued/
I am certainly very dissapointed to learn that this product is to be discontinues. A a health care professional and a diabetic, I found that Exubera provided very effective control. Morning blood sugars have never been better since I switched.
I will await with great anticipation the possible entry of Lilly or Nordisk.

Posted by Michael Treacy RN |

Six months ago, my nurse practitioner started me on Exubera. For someone who doesn’t like needles, it was a godsend! I only had to take one shot a day of Lantus, and before meals, I used my Exubera inhaler. Yes, people stared at me when I pulled out the odd-looking contraption (one of my friends said it looked like a bong), but they would certainly stare more if I pulled up my shirt, grabbed a hunk of flab and jabbed a needle into myself.
I am so disappointed that Exubera is being taken off the market. It will mean more shots per day. Perhaps that is something that experienced diabetics don’t think twice about, but for us novices, Exubera was nothing less than amazing! Shame on Pfizer for letting us down!
Posted by maestra |

6) I could not be more disqppointed that Exubera will no longer be available. It has been the best product I’ve used in the ten years since learning that I am a type 2 diabetic. I just hope that some other company will find this product cost effective to continue.
Posted by DAJ Feb 21, 02:41 PM

7) Posted by DAJ315 |
I used exubera ever since it came out. my insurance covered it at a $50 co-pay ($20 more than regular injection insulin).  it worked great for me as far as controlling my blood sugar.
the biggest problem i had with it was it’s huge size. i couldn’t fit it in my pocket. i kept it in my briefcase and when going out to eat, either i had to bring my briefcase or carry it with the risk of forgetting it laying on the table when i left.  hopfully another company will release a better insulin inhaler in the near future.
8) because i have a tremor in my hands my insulin shots keep me bruised and sore. Exubera was a godsend. i am so disappointed that Exubera is off the market. Being a diabetic is hard enough and everything that helps us is greatly appreciated. my insurance paid for it so they must have believed in it. sorry….
Posted by linda nash |
Anonymous user said:
I thought it was pretty awesome stuff, but thanks to 6 (out of 4000) old, broken down, lifetime smokers it's no longer with us. When I found out Pfizer stopped making it, it was like a little piece of me died. Now I get to stab myself a few times a day to stay alive. Such fun. 6 out of 4000! Really? 0.15%? What a shame. % of Americans with lung cancer in 2008 was 7.3%.
December 11, 2009 7:13 AM
winters748 said:
Exubera (insulin inhalation, rapid acting) for Diabetes, Type 2: My husband and I both love Exubera. It gave him more control and gave him back his dignity. He is needle phobic and I had to give him his insulin shots. This also limited my freedom as I had to be there twice a day to administer the shot. So no overnight visits to my Mom unless he went too. With Exubera, diet and exercise, he was able to completely eliminate insulin shots. He also said that the shots were very painful for him and his skin became very sensitive and bruised.
January 17, 2009 10:18 PM
blueriskbgooglemail.com (unregistered) said:
Exubera (insulin inhalation, rapid acting) for Diabetes, Type 1: I have been an insulin dependant diabetic for fifty years and have taken about 35,000 injections. I'm totally convinced that Exubera is the greatest development in the treatment of diabetes since the discovery of insulin. I have been on Exubera now for two years but have supplies left for only about 4 months. My blood glucose test results have improved dramatically since I started using Exubera. Would one of you medical companies please please restart production but this time market it properly.
January 4, 2009 1:27 PM
Anonymous user said:
Exubera (insulin inhalation, rapid acting) for Diabetes, Type 2: I have been using Exubera from its first availability and it has greatly improved my sugar level. It's much easier than using injections. I will be eagerly awaiting its future and hope that another drug company will be interested in supplying it as Pfizer has decided to no longer make it.

At October 26, 2007 8:05 AM , Anonymous Anonymous said...
On Friday, October 18, Pfizer announced that they would no longer be producing
Exubera, the ONLY NON-INVASIVE insulin available to the public. Now, this stop in production is not due to safety concerns; it is due to Pfizer not making as
much money as they had hoped. So, Pfizer, who generates over $48 billion in revenue annually, plans to stop making a drug because it isn't making as much
money as they had hoped after only one year on the market?

The FDA approved Exubera in May 2006 and Pfizer didn't begin producing the drug full force until 2007.

My story with Exubera started over 6 months ago. I have been a Type I, insulin dependent diabetic for 24 years. I have taken on average of 4 injections a day,
which accounts to over 35,000 injections in my 32 years of life. When I heard about Exubera, I was ecstatic. I said "this is my cure". My doctor and I
decided to try it and after a few weeks of regulating it; I was very pleased and excited to lead a normal life, without 4 injections. I was able to go down to one injection a day and sent my spare bottles of insulin to a non-profit company who distributes them to those who can't afford it. I have been an Exubera user
ever since then and was shocked, angry, and heart broken when I found out from a friend, not Pfizer or Exubera, that Pfizer plans on stopping production. As I read information on why, I got angry that the reason Pfizer provides is because lack of revenue. I know Pfizer will say I have other options, but do I really? I can't have an islet cell transplant due to anti-rejection drugs; I can't take
a pill because I am insulin-dependent. My only option is to go back on 4 injections a day: to have bruised, sore arms and legs again and to have to get
up and run to the bathroom to give an injection before breakfast, lunch, and dinner or to get gawked at if I give an injection at the table in a restaurant. Exubera is my cure. I don't have the luxury of not taking insulin. I need it
to survive. This may be the closest thing to a cure that many Type I diabetics will ever see and Pfizer should not be able to just write off a medical innovation that changes so many people's lives.

Pfizer says on their web site, "That's why we at Pfizer are committed to being a
global leader in health care and to helping change millions of lives for the
better through providing access to safe, effective and affordable medicines and
related health care services to the people who need them" (Pfizer.com). Instead
of Pfizer improving my life they are taking away the ONLY non-invasive treatment
option for me and the 3 million Type I diabetics in the US.

I would love to sit down with the person who made the decision to take it off the market and give him or her 4 injections a day for a week, let alone 20
years, and see if he would change his mind.

Fight4Exubera@aol.com or http://www.myspace.com/reen910

I have to confess, I use Exubera. I have been a user since Jan 2007. After my doctor told me I had diabetes, he told me about this new inhaled insulin and gave me a prescription for it. As far as I was concerned, that was the only positive thing that came out of that visit, it made me smile. At the time I was relieved that I wouldn't have to give myself shots. (That was before I knew anything about diabetes and basal insulin. I found out three days later that I would still have to inject insulin, I use Lantus for that)

Three weeks later when I had my first visit with my endocrinologist, I got the distinct impression that he didn't think Exubera was going to work very well. But by then, I had gotten my blood glucose under control and we decided if ain't broke, don't fix it.

Three months later I am still using the Exubera before meals. I think my endo is surprised that its still working for me. Despite the success I've had so far, there are some issues with using it:

1. The dosing seems iffy and doesn't seem to allow for much flexibility. I have to clean the inhaler every week and there is insulin that is still inside it (shouldn't that be going into my body)? Also, when I remove the blister from the inhaler, some insulin spills out on occasion, oops. Also, there are only two doses, 1mg or 3mg. This really doesn't give you much flexibility in adjusting your dose depending on what you are eating.

2. Yes, the inhaler is huge and takes up a lot of space in my bag. The first time I used it, my husbdand and I dubbed it my "crack pipe".

And, yes, I have used it public, just like the guy in the video. There are some times when I sneak away to the ladies room to use it (depending on where we get seated at a restaurant and how many people are around us). But, for the most part, I'm less self-conscious about how it looks.

The true test will come next month when I get more blood work done and find out how my A1C has been while using it. Until then, if it ain't broke...
Melissa
Keith said...
A couple of comments from her PSP. One of the big issues she ran into is the dosing, you really never are sure how much you get. So when we try to eat something new and her blood glucose reading comes back high you are left wondering if it was the food or a small dose of insulin.

She mentioned the endo and his suprise at how well the exubera is working. On the plus side he said he is using this as an example that exubera can be used successfully. However, I suspect it is only a matter of time before she is using an injection at dinner.



12) 9:44 pm June 18, 2010

I Just finished the last of my Exubera. The company sent large quanities to me when it was dis-continued via a prescription from my doctor. I have been back on shots now for a couple of months and I can say that the down side to Exubera having been discontinued due to Horrible marketing is a tragity to diabetics. Exubera was very easy to use, despite some claims I could take it faster than I could load a needle. I could take it any time, so if blood sugar is a little too high after a first dose, it’s easy to take more, easy and painless. It was easy to take anywhere without refridgeration. It controled my blood sugar H1AC levels much better (7.1)… After having used inhaled insulin probably longer than almost anyone else (From it’s emergence on the market to spring of 2010) I can tell everyone this is clearly the way to go. I am always amazed when I meet a diabetic who has no knowledge of Exubera, inhaled insulin, and now Mannkind. This is a product that will improve the health of diabetics everywhere, thus lowering health care costs, I know I am an example.

Feedbacks from Real Afrezza users

By SharpTail (diabetesforums.com)

02-09-2008, 09:09 PM

The removal of Exubera from the market is old news for sure. They had problems marketing the product and the inhaler was not a convenient advice.

Beyond being a different method of delivering insulin this may be a valuable tool for both MDI and pumpers to manage their diabetes. As some of you know I have been participating in the trial for about 1 1/2 years now for Technosphere insulin. This period of treatment has been my best for control for over 25 years. Part of the reason is the fast action of this insulin and the short period of action. For me in less than 2 hours this insulin is out of my system and there is not an unexpected drop in my blood sugar level due to left over insulin action. The other great thing about the very fast action is for a correction dose. For example I have forgotten to bolus for a meal and discovered a high blood sugar of 18+ two hours after the meal. In less than an hour I have consistently been able to bring my BS level to a normal reading of 5-7 with the Technoshpere insulin. There are definitely some positive features to this medication.
Pat

02-10-2008, 05:24 PM

When the inhaled Technosphere insulin will be available is unknown to me(you can Google this to find our more information). I believe I am in the final phase of the trials. This is a two year trial ending in July 2008 with the objective of assessing whether there is an impact on pulmonary function. Also this trial is being conducted in the US, Canada and in Europe so I assume the Mannkind company will try to get approval for this insulin in all of these countries. I would think they will submit the results of all their trials as soon as possible.

I would certainly not describe the TI insulin as a "wonder" insulin. Inhaled insulin has receive a lot of bad press for sure. However, the way I look at it even individuals with no fear of injecting insulin may occasionally have a use for such a fast acting insulin regardless of how it is delivered. I could definitely see it being used to give a "kick" to a usual bolus of injected fast acting prandial insulin if a meal includes very quickly metabolized carbohydrates. Also, it will work wonders for very fast corrections of high blood sugars as in the example I gave in the last post. Personally for me the absence of that "left over" and somewhat unpredictable insulin 3-4 hours after a meal has just about eliminated any bad hypos. I should say that the other important part of the equation is my injected Lantus for my basal requirements.

There are also some downsides with the TI insulin. For very insulin sensitive individuals the available dosages may be difficult to work with. Exact conversions to the injected insulins may be a challenge. Also, as may be expected, an aerobic activity that increases blood flow to the lungs within an hour or so of an inhaled bolus greatly accelerates and increases the action of the TI insulin. I have found that in this situation the action just about doubles. I suppose this feature could be used to advantage, but with caution as well. Of course all of what I am saying is anecdotal and we will have to see what the final analysis of the data tells the researchers.

I was in the clinical trial for Technosphere Insulin for 2 years. If you liked the Exubera you would definitely like the TI insulin. If you Google "Exubera Technosphere status" you will find information about some patients who were on Exubera and are now using the Technosphere Insulin as a replacment.
Pat

__________________

10-23-2008, 08:56 PM
Type 1 Diagnosed November 1981 at 29 years old
Clinical Trial with Technosphere Insulin until July 2008
October 5, 2009 began pumping with Animas Ping, great technology!

06-23-2008, 09:41 AM

Technoshpere Insulin Trial Finished


I just completed my 2 years participating in the inhaled Technosphere Insulin (TI) Clinical Trial. I believe this was Phase Three, the final phase before the results will be submitted for approval for distribution in North America (Canada and USA) and some countries in Europe.

The TI insulin worked well for me. I started the trial in the summer of 2006 with an A1c of 6.8 and the last tests taken on May 28, 2008 it was 5.9. This is the lowest A1c I have ever recorded. A notable fact was my ability to tighten my control and yet in that 2 year period only have one incidence of a significant hypoglycaemic episode. Part of this is due I am sure to more frequent monitoring of my BS and also to more accurately adjusting my doses of my basal Lantus. I found I needed to split my Lantus, since I was only getting about 18-20 hours of coverage. My basal Lantus is working very well for me right now.

I think a lot of the refinement of my control came from the rapid onset of action and also the short period of action (2 hours or less) of the TI insulin. I found the second hour of action of the TI insulin to be very gentle. Generally I bolused with the inhaled insulin immediately before a meal and sometimes during and after a meal after I determined precisely what I was eating. The lack of lingering action with the TI insulin in the 3-4 hour period like I expect from Humalog helped to minimize an unexpected drop in my blood sugar with a resulting hypo.

The Technosphere Insulin Inhaler did not suffer the problems of the Exubera Inhaler. Since it is hardly bigger than a cell phone, I usually carried it in my shirt pocket when I was eating in a restaurant.

A limitation for some especially insulin sensitive individuals may be the dosing for the TI insulin. Basically there are two doses to work with in various combinations. For me I found them quite easy to figure out and work with in most meal situations. I found if I overestimated the dose and my blood sugar dropped too low the fall of blood sugar in the second hour after bolusing was very gentle and never "crashed" like I became accustomed to with injected Humalog. Therefore no bad hypos.

For the Trial I was required to keep the TI insulin cool like in refrigeration when I travelled which was a burden at times. However, I think this was largely for control during the trial. I have read that the TI insulin can be kept at room temperature for up to two months which is better than injected insulin.

Now that I have been on Humalog for about 3 weeks I am surprised at how slow this insulin is. It is like I was driving a Ferrrari for two years and now I have to settle for a pickup truck. The truck gets the job done, but in its own time. I discussed in Eddy's post about intramuscular injection of the prandial insulin. I have found using this method of injection with the Humalog I have quite closely matched the action of the inhaled Technosphere Insulin.

Needless to say I am disappointed I will not be able to continue to use the TI insulin in the near future. I am not sure I can maintain the A1c of 5.9 with the Humalog, but I will be giving it my best effort. There is some information that there may be a continuing long term trial with the Technosphere Insulin in the future. For me the inhaled feature of the TI insulin was only a different method of delivery. I think the rapid action and short duration of action was more significant in my success with this medication.

Pat

02-27-2008, 08:04 AM

This device, called the Medtone Inhaler, has been shown on their website at Mannkind Corp | Mannkindcorp.com for a long time, so I'm not revealing any "secret". I would think they would like some positive press if they can get it, considering the stain left by Exubera on the "inhaled insulin" concept.

Actually there are two dosages that can be used in different combinations to give the "correct" dose. The smallest dose for me is about equivalent to 2U of Humalog. Personally I would like to see the option for a smaller dose and that would give individuals with high insulin sensitivity almost all the options they would require.

If you disregard the fact that the delivery system is through the lungs, the TI insulin has some properties that could be valuable as an additional tool to control blood sugars. In 10 minutes or less it is working at full "power", but is completely out of your system in less than 2 hours. I think that this short period of action is one reason I have had no serious hypos since beginning this trial in the summer of 2006. Yet I have been able to tighten my range of BS levels and lower my A1C from the high 6's to 6.2 for my most recent test this month. It is quite amazing how this works for rapid corrections of high blood sugars. I can expect to bring my BS levels from 15+ to a good range of 5-7 in less than an hour and you can cut that time by 1/2 if you associate that with an aneorobic activity that will increase blood flow to the lungs.

Certainly the control of the dosing for this insulin may present problems for some individuals if it is used exclusively as a prandial insulin. However, even for those who "micromanage" their dosages, there could be uses for the TI insulin in exceptional circumstances such as for corrections and quickly metabolized carbohydrates.

I have wondered if after this insulin gets approval after the trials, whether it will be priced competitively with other insulins and also covered by insurance. We'll have to wait and see. In July when my 2 year trial is complete I will have to make the adjustment back to Humalog and I know I will miss having the TI insulin.
Pat

Posted by anehamkin Thu Jan 04, 2007 9:42 pm ; from dlife.com

(This is the only other Afrezza user)

The insulin that I'm on in not Exubera. It's the one that's still in clinical trials by Mannkind Corp. This one is about the size and shape of a small throwaway camera.It's actually very convenient and just carry it in a little pouch. Have to carry the insulin powder in something cool though. It's just a small vial that snaps into the inhaler for each dose. It took getting used to and have a slight cough periodically. I've had 3 pulmonary function studies so far in the past 6 months that are required for the study. This is so simple and after 33 years of diabetes and injections, a welcome break. I still take Lantus once a day which is not a big deal in comparison. It beats the 3 add'l injections of Novolog each day. I don't understand why some diabetics are so adamant about not trying new products. Everything is new when it first comes out and someone had to be a study for it. I was actually part of a study for the insulin pump back in 1972, when it was nothing more than an insulin IV. And look when it is today. Anyway, is anyone else on the Mannkind study? I've been in it 6 months now and I feel almost like a new person. And yes, the powder down lower your blood sugars. You just have to find the right dose to calculate. Gets a little tochy sometimes, but worth the effort.


Monday, February 22, 2010

Basic control theory

This quote (in italics) is from Al Mann Q4-2007 Earnings call

What Technosphere Insulin does is to control cranial glucose excursion better than any other product, insulin or otherwise. But what Technosphere Insulin does not do is to control fasting glucose levels. Because of the overriding fear of hypoglycemia in the real world of diabetes therapy, most physicians manage their patients at shockingly high fasting glucose levels that can surely lead to serious complications.

With a fasting level of 180 milligrams per deciliter, a common clinical practice today is the fasting level that primarily determines the HbA1c. With a fasting level of about 100 milligrams per deciliter a near normal levels cranial excursions effectively determine HbA1c. To achieve a nominal HbA1c a patients must control both cranial and fasting levels.

People essential face two independent sources of glucose, that from meals and that supplied by the liver to fuel the body between meals. What we have here is truly exists a classic case of two various controls. Basic control theory teaches that for good control, both of these glucose sources must be independently addressed.

The only insulin formulation that does address cranial level separately from fasting modes is Technosphere Insulin. No other insulin even comes close. Good control cannot be achieved through cranial kinetics that is at least those achieved as good as Technosphere Insulin is. So please don’t compare Technosphere Insulin to Exubera.

My comment:
What I find it amazing is, the analysts and the researchers do not seem to place much emphasis on this data point. The immediate inference is, Afrezza is better suited for Type 2 who are currently taking basal insulin. What the type 2's really need is just the bolus Afrezza to take care of the meal time glucose.

A picture is worth a thousand words and the following graphs show how Afrezza is in the league of its own; the reason for this differentiated profile are, Afrezza is delivered by inhalation (high bio-availability, huge alveolar surface, immediate access to blood stream) and the insulin is in the form of monomer.

Click on the picture to see it better