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Monday, 06/27/2016 9:21:37 PM

Monday, June 27, 2016 9:21:37 PM

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If your invested in MNKD READ ALL BELOW. imho.



Who Appears to Benefit Most from Afrezza?


Most of those reporting their results on Twitter (the only place where there is much discussion of Afrezza) are people with Type 1 who had been having a great deal of difficulty controlling their blood sugar using the tools that many other Type 1s have been more successful with, like pumps and CGMS. Several of these have reported dramatic decreases in A1c. They also report being able to tolerate a higher dose than the corresponding amount of injected insulin they usually use.

This suggests strongly that a unit of Afrezza is about as effective a half a unit or less of injected insulin I have seen no reports from people with Type 2 who have the kinds of blood sugar levels that would motivate most physicians to prescribe insulin--i.e. blood sugars ranging from 300 mg/dl to 400, mg/dl after meals.

The very few Type 2s posting about Afrezza, some of whom are also investors, appear to much milder forms of Type 2, some of which verge on Prediabetes. Afrezza works well for them, as we would expect it to, since the dominant feature of early Type 2 (and prediabetes) is the loss of phase one insulin release that occurs in normal people right after eating and the persistence of the later, slower phase two insulin response.

However, since the target person with Type 2 who is most likely to be prescribed insulin rather than one of the newer, expensive and highly risky orals, is a person who no longer has any second phase insulin response left, it is questionable how well they will respond to Afrezza. Because Afrezza will only cover the high glucose that results during the first hour after eating.

The persistant glucose "long tail" these Type 2s experience after eating will not be covered by the short-acting Afrezza.

This probably explains why the FDA approved Prescribing Information for Afrezza only discloses the results of a study in people with Type 2 where Afrezza was compared against the use of no other insulin, just oral drugs.

My guess is that Afrezza does not compare well in people with advanced Type 2 diabetes when pitted against a basal/bolus regimen with fast acting insulin injected at meals, or for that matter against 70/30 mixes, as I believe it was matched against that kind of insulin in trials run as part of the drug approval process, which are not cited in the Prescribing Information.


The Downside of Afrezza: Pricing and Packaging

As mentioned earlier, most of the Type 1s who are using Afrezza successfully are using one or more correction doses after meals and at other random times of day when blood sugar starts to rise. But Afrezza is much more expensive than the same number of units of injected insulin,

and the way that Afrezza is dispensed, in 90 dose packages, means that a person will need a second, very expensive, package to have enough to give themselves a correction dose.

Another problem with the packaging is that Type 2s put on insulin are not given much diabetes education, unlike people with Type 1, and few are taught to administer correction doses. Instead, most are just told to use a set amount at meal time and may have trouble figuring out how much to use for a correction. They may also have trouble, given the way the drug is currently packaged getting enough insulin to cover three meals a day, since the packages containing the largest doses available, the 12 unit dose, also include smaller dose cartriges. This makes it necessary to order several boxes to provide even three 12 unit doses a day for one patient. And of course, the typical Type 2 who needs meal time insulin is more likely to be using 20-30 units at a single meal than 12, which becomes even more problematic when you remember that 12 units of Afrezza may be the equivalent of much less injected insulin. So the expense of prescribing Afrezza in truly effective doses to people with Type 2 diabetes is such that we aren't likely to see many insurance plans approve this drug any time soon unless the companies making and marketing Afrezza drop the price dramatically and rethink the way it is currently packaged. For now, the difficulty of providing large enough doses to cover meals for people with insulin resistant advanced Type 2 diabetes, combined with the apparent need to use, and understand, correction doses, may keep this from being widely prescribed to the people with Type 2 who need insulin but fear needles.

Afrezza is Best for People with Type 1 and Very Recently Diagnosed, Mild Type 2
The success stories we are hearing about Afrezza are from people with Type 1 diabetes, for whom the doses supplied in today's packaging options are appropriate.The little bit I've been able to garner from what I've read and heard from people with Type 2 using Afrezza suggests that it is also working for people who are not extremely insulin resistant, whose whose blood sugars are extending perhaps into the mid 200 mg/dl range after eating high carb meals, and who have extremely good insurance and the ability to convince a doctor to prescribe this drug to them.If you fall into that category, it would be worth a try.
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