My Discussion of Diamyd's Phase II Human Trial Results.

Yesterday, Diamyd announced the results of their Phase II trial using GAD65 on type-1 diabetics. Their web site is www.diamyd.com, and their presentation and webcast are available as links on that page.

The treatment was two injections given one month appart to type-1 diabetics

who were between 0 and 18 months of dx, and still had some C-peptide

activity and "tested positive for GAD65". The results were that diabetics who got

the treatment generated a lot more of their own insulin when they ate food. (I

think about twice as much, but hard for me to tell.) Total size was 70 people, so

35 got treated. Multi site study in Europe (Sweden, I think.) Effect lasted

for 15 months. No bad side effects.

Obviously, this brings up many discussion points, some of which I will cover below:

1. Is this a cure?

This trial was not a cure. Everyone continues to use insulin and do many BG checks. This treatment MIGHT grow into a cure, but even that is unclear to me.

2. Is this a honeymoon only treatment?

Not exactly. The diabetics who had just dx and the ones who dx 18 months before, had similar outcomes statistically (and 18 months is longer than most honeymoons). The study was limited to diabetics who had "fasting c-peoptide 0.1 nmol/l or more" and "Positive for GAD65 auto antibodies". and these seem to be the key measurements.

Not the number of months since dx. (Although I think these are related, they are not the same.) I have no idea how many diabetics, and especially how many non-honeymoon diabetics, fit these criteria. Does anyone on this list know?

3. If all this treatment did is require less insulin, what's the benefit?

The treated diabetics still had to inject or pump insulin, it is just that they used less, because their bodies generated more of their own, so what is the benefit of this treatment? (Assuming it is used exactly as tested.)

The Diamyd people think, and I have heard elsewhere, that generating more of your own insulin leads to far fewer long term complications. That diabetics who generate more of their own insulin get fewer vision problems, kidney failures, and so on. The really bad stuff that happens after 40 and 50 years.

I think they also said that generating more of your own insulin leads pretty directly to better A1C numbers, which leads to much the same thing. I don't doubt this.

4. Were there really no bad side effects?

They guys from Diamyd were adamant: no bad side effects. Their data shows that the rate of "adverse effects" for the two groups (treated and control) were about the same. They said during Q&A that the adverse effects reported were things like getting mono and breaking a limb, which they did not think had anything to do with their trial, and just had to do with having teenagers involved.

5. Can this treatment grow into something more than it is now?

I think so, but there is no way to be sure. Amost any treatment can get better as more studies get done, and more doctors get more experience using it. However, in this case, because there are no bad side effects, it is likely possible to either up the dosage, or give more injections. Either of which might lead to longer or stronger effects.

For me the key questions are these:

a) Are there any long term bad effects?

b) Do bigger doses lead to better effects? (Can we eliminate insulin using this treatment?)

c) Does longer treatment lead to longer effects? (Can we use this treatment for decades?)

d) How many diabetics, and which ones, will benefit from this treatment?

I hope that people with a strong science background than I have, will read the presentation and listen to the web cast, and help me interpret it.

I listened to the web cast at about 9am this morning, next time, I will listen to it live. They took questions asked by random people who were viewing the web cast, and some of those questions (and answers) were the best part of the talk. Even if you areboard by the presentation, I would still fast forward to the Q&A part.