Guess What the FDA Passed?

[SunniD]

The FDA in the States just passed a new short acting insulin.
It's called "Apidra" and is put out by Aventis. It should be
available shortly unless more paperwork holds it up!!

This insulin is twice as rapid as Humalog and Novolog for action time and should be great to pump with!!!!

If anyone in other countries sees that this insulin is for sale, let us know when it hits the market as I would be interested.

This info came from an official source which I trust so should
be reliable.

SunniD

[Oradev]

Do you know when it will pass levemir.

[JasonSmithMT]

SunniD - where did you see the "twice as rapid as Humalog and Novolog" at?

I was looking at the FDA Approval Letter (PDF document) (http://www.fda.gov/cder/foi/label/2004/021629lbl.pdf) and Aventis website (http://www.aventis-us.com/PIs/apidra_TXT.html) and I'm not seeing good pharmacokentic comparison of insulin glulisine and lispro. The package is going to be labled the same as lispro - that is "15 minutes before ... "

Let me know if you know of a good comparison.

Thanks - Jason

[SunniD]

The comments I made were from a CDE who had gotten officially informed and perhaps it is just his interpretation but the FDA site you listed says that it is

Quote more rapid in onset and of shorter duration compared to regular human insulins Quote

The Aventis site says if you give Apidra 2 mins. before you eat you will get the same bg as a regular human insulin injected
half hour before eating so that's more than twice as quick.<smile>
The duration may not be as long but this is sure acting quickly to lower bgs.

The same CDE told me about Letemir awhile back so I was under
the belief that it had already passed FDA or he wouldn't have said anything.

Sorry Jason don't know of any comparisons but will keep an ear
open to find some. That would be my good ear.<smile>

SunniD

[JasonSmithMT]

SunniD -

Just in case you wanted to know. I finally found a study done by Becker, et al. that was published in the June 2003 edition of Diabetes. You can look at the MICROMEDEX website (http://www.micromedex.com/products/updates/drugdex_updates/de/insulin.html) information on Insulin Glulisine that lists some of the results of their study.

It looks like to me that it has the same pharmacokinetic and pharmacodynamic profile as Insulin Lispro.

I'm getting ready to switch to a pump and thought that maybe a more rapid acting ananlog would be great. But come to think of it would it really. It might act too fast. It takes some time for the food you eat to convert over to glucose. One might have to bolus after a meal just to be safe.

I did also see on one website that Aventis is going to wait until they get approval of their Apidra Pen before they release it to the US market. I don't remember where I saw that information so I don't have a link. Sorry.

Jason

[SunniD]

You might be right about when to bolus Jason. I was thinking of how fast one goes into DKA if there's a set problem and was wondering if that also would speed up slightly. Don't think so as
it appears so similar to Insulins Lispro that it should be very similar. I've had a couple of quicksets that have broken, one during sleeping hours so by the time I awoke I was well into DKA.
Had a ketone of 2.6 and a bgs of 25 mmol/L but when I gave a shot of insulin my bgs shot up to 33.5. I was getting close to having a cordial greeting by my meter "HI". <smile>

I had trouble with Humalog insulin so am not sure about the ecoli
growth it's made up from. I'll stick with Novorapid for now as I
don't seem to have as many problems with it. Always wondered about things grown in ****<smile>.

Lots of rules getting clearance for Apidra Pens too.
Thanks for posting all the websites for Apidra-it was real interesting reading.

Gool luck on getting a pump. It makes my life a lot easier however
I never did get a letter from my endo. They make promises and
then don't deliver here just like the insurance company.
I'm quite upset about this as you can probably tell. You would think that the money was coming out of the docs pocket but
instead he's making it come out of mine and it hurts without getting the letter for coverage. You would think that after having Diabetes for 43 years a doc would have a little more compassion for me. I feel like this: wre[pikt4p[k 4eojf[p1 o3 [2ke and my doc
can put that on his toast and eat it too.*g*

I wonder if he knows that I work for the doctor who is the head of the medical association here. <smile>

SunniD