New inhaled insulin

I have no idea how on G-d’s green earth I missed this one. Courtesy of Google:

MannKind Corporation to Review Positive Results From Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes

Live Broadcast on December 18, 2008 at 9 a.m. Eastern Time

VALENCIA, Calif., Dec. 15 /PRNewswire-FirstCall/ – MannKind Corporation (Nasdaq: MNKD) will host a live broadcast to review clinical results from its final two Phase 3 studies of AFRESA™, the company’s ultra rapid acting, inhaled insulin product, at 9 a.m. Eastern Time on Thursday, December 18, 2008.

The results they released so far showed no pulmonary complications and equivalency to injected insulin (based on A1c), according to

They plan to submit a new drug application to the FDA in early 2009.

(EDIT: For phase II results in T1s, see:

Dear Dov.

Not a good idea. Has been tried. It think the exubera was dicontinued in Canada. Spoke with lady that was trying inhaler and she said she had poor control. My friend Dr. Cox ( anasthesiologist) said he would not think it was safe and said we have already enough crap in our lungs.

Useless for T1’s too because dosing is so imprecise.

What a wasted effort. Injecting insulin is not painful or difficult.

They seem to feel that it’s good for T1s and T2s, and allege that their study data backs that claim. They also claim that it has no significant pulmonary effects. The pulmonary effects and the clunky administration device were the problems with Exubera, and this drug seems to address those issues.

As for injectible insulin, for those of us with very shaky hands (or those with severe needle phobia, which I am not), injecting can be a real problem, so, from that end at least, it seems like a good idea. Personally, I was going to look into a jet injector if I should need more than the one injection a day, but will wait and see.

The problem with basing the testing on A1c is that it is a very poor gauge of actual control. The earlier inhaled insulin, Exubera, was impossible to dose to match food. it was dosed by body weight!

So what they do with these kinds of insulins is get a big group of people who are in terrible control or who don’t understand how to use basal bolus insulin and insulin/carb ratios, or people using 70/30 insulins twice a day and use them in their studies. They get equivalent A1cs because everyone in the study is doing poorly.

I don’t know what the truth is about this new version, and since the article you cited is a press release, not an objective report, it probably won’t be clear until we can see the actual studies–full text, not just conclusions.

But the critical issues with all these oddball insulins is can an insulin sensitive person dose them to match food. WIth Exubera, one dose did not cover 1/2 of what 2 doses covered, for example. So that is what you should keep alert to.

There is also an oral insulin under development, which is absorbed through the cheek if I recall correctly. And a much faster acting version of R insulin which is injectable but would be a nice option for those of us who worry about the analogs not being bioidentical.

Dear Jenny. Wow a faster acting fast insulin would be good.

The buccal insulin to which you refer - Oralyn - is also being tested against NPH, so we’ll have to see on that as well. It, and this one, are supposed to be effective much faster than Humalog. You are right that we need to see the studies; was passing this along as “of interest.”