Three Months Of New Studies

Type 1 & LADA T1 Research
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I’ve just posted a new blog, which is a little different than my usual blogs. I went through all type-1 diabetes clinical trials which started in the last three months, and counted what they were focused on and which ones were focused on a cure.


You can see how much research is aimed at new types of insulin, better treatments, potential cures, etc.

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Very interesting post, @joshualevy.

As always, I am personally a bit disappointed by the low percentage of studies looking at a cure (3 out if 41). I find the number of insulin studies surprisingly high (8), but with no great progress in expectations: adaptive insulin does not appear to be for the short term.

In the tech studies, I am noting the interesting 3-substance artificial pancreas study from McGill. But McGill was also pioneering a 2-substance artificial pancreas a while ago (insulin/glucagon) that still does not appear close to market, if ever.

Hopefully, the very high number of treatment studies (16 of 41) may provide some actionnable items.

Again, great blog: you render an extremely valuable service to the D community!

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Have you checked out Faustman Labs research? Denise Faustman has found using an old TB vaccine results in getting some insulin production back in type 1’s. She just started a larger phase 2 trial. Wondering what you think if this?

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I agree that 3/41 studies aimed at a cure is way too low, and that is one of the reasons that I made that post: to remind everyone how little research is really cure focused.

For the 8/41 aimed at new insulins, that is pretty common. Maybe even low. New insulins have a clear and well understood path to a profit, so there are always companies working to make money that way.

Joshua

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I’ve been following Dr. Faustman for over 10 years, and have published 19 blogs on her work over that time. You can read them all here:

But if you only have time to read two or three, I’d focus on these:

I’m happy to discuss any aspect of this work with you, especially if you have any specific questions about it.

But if you want a quick summary of her most recent publication, these would be my opinions:

  • In terms of a cure, Dr. Faustman’s human trials are moving away from a cure, not towards one. Her C-peptide data from her phase-I trial years ago was tiny, but in the right direction. Her most recent C-peptide data from that same trial shows no improvement (not even the tiny goodness that was seen before).

  • Her phase-II trial is not using C-peptide data as either a primary or secondary outcome. C-peptide is the standard measure for progress to a cure, so not having it as a primary or even secondary outcome means this research is no longer “aimed a curing type-1 diabetes”.

  • Even worse, her Phase-II study originally was originally going to measure C-peptides, however she dropped that a few years ago. The primary end point is now A1c data, but A1c is the measure of better treatment, not a cure.

  • The good results reported were very time dependent, and inconsistent. The results at 4 years were good, and that is what she talks about. But the results at 2 years were bad, and she does not talk about those. The most likely cause of all this (in my opinion) is randomness of the disease. We all have better and worse times with type-1 diabetes. If the vaccine had any impact at all, then the impact is to make A1cs worse for the first few years, better for the next few, and then start to move back to were they started. (You can see the graphs in my blog.)

  • Her good results are due to a bad-science technique called “results swapping”. She started out studying one set of results (autoreactive t-cells, c-peptides, TNF, etc.) but none of those gave good results, so she ended up publishing data on A1c numbers, which was not part of the study to start with, and the study was not designed to report on those.

  • In her most recent paper, she said very specifically that her TNF theory, which she has been working on for 10+ years was not causing the results seen in studies. She proposed an alternate theory, but that alternate theory is one of treatment, not cure. It is similar to some of the type-2 treatments available now.

My most recent blog posting on her work goes into a lot more detail about how badly things are going, and the misleading language used in her most recent press release.

Joshua

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@joshualevy, thank you for what you do, and a hearty thank you for cross-posting to our little corner of the inter-webs.

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Thanks for the info and insight. I knew it was just showing signs of a treatment for reduction of insulin need not a cure but learned more today from your post. I will read all articles when i have time.
In your opinion do you think this research will end up useful in any way?

What is your best hope in terms of a cure of the current research?

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I’ll try to put a blog posting together about my best hopes, but it will take a few weeks. I’ve got some in line ahead of that.

Joshua

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