May 17, 2011

I Was Wrong.

I know! Who would think I could be wrong?

(That should get a long list of comments consisting of “Me” and let me just say hi to Tim who will be prominent on that list.)

In addition to all the playing nice in the sand box with JDRF that I reported about in yesterday’s recounting of Scott and Bennet’s excellent JDRF IDDP adventure, we did have some specific questions. I know one of mine was about Amylin and leptin analogs.

As an aside I was not only wrong but also daft, I just finished a class, for which I memorized stuff about leptin but somehow couldn’t associate metreleptin with leptin but enough of my digression about being daft. (Which I am also sure Tim will appreciate.)

Leptin, is hormone produced in fat tissue that plays a key role in regulating metabolism. My text book says it does this "by affecting hunger. As your fat stores increase, leptin signals the brain to decrease your level of hunger and food intake." (Joan Blake, Nutrition and You, 2012, Benjamin Cummings, one hundred bucks but I am not bitter about the price)

Anyway, I made note of JDRF entering into an IDDP project with Amylin last November for  a study of metreleptin. I know that I was confused when Amylin and Takeda announced a suspension of trials of pramlintide/metreleptin. (Pramlintide is marketed by Amylin as SYMLIN® just in case there isn't enough name confusion.)  I was very confused, particularly when I found a JDRF newsletter in the mail that had an article on Amylin a few weeks later.

So here is the straight story. These are two different studies of the same analog, in different groups, for different reasons. The JDRF IDDP is still on.

Let me quote JDRF:
... to follow up on our conversation from last week about the recently halted metreleptin study, which you had asked about.  As we discussed, Amylin and Takeda Pharmaceutical Companies recently suspended clinical activities in an ongoing Phase 2 study examining the safety and effectiveness of an investigational combination therapy using pramlintide and metreleptin for the treatment of obesity. This is a separate trial from the metreleptin study JDRF and Amylin are collaborating on.
They go on to say:
As for the metreleptin study that JDRF and Amylin Pharmaceuticals are partnering on, we, along with The University of Texas Southwestern in Dallas (the institution where the trial is taking place) will continue to monitor trial participants in accordance with the team’s diligent safety monitoring strategy, which has been approved by the university’s Institutional Review Board and FDA.  Additionally, in light of the recent findings with metreleptin in the above-mentioned obesity trial, the team has consulted with the FDA and will continue to as the study proceeds.
So there you have it folk, I was wrong when I thought they were the same investigation. I don't think I wrote anything here about that confusion but I am sure I was confusing none the less. On the plus side, I now know how to get fast answers to questions like, “Hey was that the Amylin study JDRF did an IDDP with?“ when I am reading the news.

There you have it, YDMV - fairly accurate-ish.

p.s. I don't think either of these is the May 10th IDDP on mixing insulin and SYMLIN®.... maybe I better check.