Current Research into Cures for Type-1 Diabetes: August 2015

Wednesday, August 19, 2015

Research In The News (August)

This blog posting contains bits and pieces of news on type-1 diabetes research aimed at a cure.

The Phase-II Trial of Secukinumab Was Terminated

The phase-II clinical trial of Secukinumab was canceled in June 2014. I have not seen any public notification about why it was canceled. Apparently five people were dosed before it stopped, but I have no idea if any results will be published or not. This trial was being run by Novartis.

You can read my previous blogging on this trial here:
http://cureresearch4type1diabetes.blogspot.com/2014/05/secukinumab-and-ustekinumab-each-start.html

Reporting: http://webcache.googleusercontent.com/search?q=cache:-Iu_s9VcSmwJ:adisinsight.springer.com/drugs/800023920+&cd=1&hl=en&ct=clnk&gl=us
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02044848

Phase-II Trial of BCG By Faustman Starts Recruiting

I made a big announcement when Dr. Faustman announced she was ready to start her phase-II trial. However it took over a year to actually start recruiting patients. The blog I wrote previously is still accurate (except as described below), so If you want to know what is going on with BCG, I'd start out by reading my previous blog:
http://cureresearch4type1diabetes.blogspot.com/2014/04/dr-faustman-starts-phase-ii-trial-for.html
and then consider the following updates in the last year:

First the good news: it will include 150 patients, rather than 120 as before.

Second, the bad news: the delay means the study will complete in 2023 rather than 2022 as before (which means publication in 2024 is a reasonable goal).

Third, a change in primary outcome. The study as I read it now, is going to have A1c measurement as it's primary end point, and C-peptide measurement as a secondary end point. Previously, I had thought that both would be primary end points, but I might have just misread the clinical trial registration.

However, no matter which is primary and which is secondary, the important end point is the C-peptide numbers, not the A1c numbers. For cure research, C-peptide is a much better measure of success than A1c. C-peptide is what the FDA requires for cures, and that is what measures how much insulin your body is creating itself. A1c, on the other hand, is a good measure for type-1 treatments. So in this case, in 2024, when we are looking at the results, it will be the C-peptide results that matter.

I don't see that there are any other major changes from a year ago: no change to dosing regimen and no change to duration.

Press Release: http://www.eurekalert.org/pub_releases/2015-06/mgh-mgh060315.phpClinical Trials Record: http://clinicaltrials.gov/ct2/show/NCT02081326

Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

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This blog discusses cures and preventatives for type-1 diabetes that are either in human trials or just about to start. Treatments for diabetes are not generally discussed here, unless they can turn into a cure or a preventative. My definition of a cure is this:
1. Blood sugar control without testing and with doctor's visits 4 times a year, or less. Any cure must result in an average lifespan close to normal.
2. Does not require a lifetime of immunsuppressive drugs, so it is not trading one treatment for another. (but a couple of operations, or a short course of drugs is OK)
Obviously, this is my personal definition of a cure; yours may differ.
Because a cure for type-1 diabetes is likely to involve a combination of several different drugs or treatments, I try to follow research into anything which may be an important part of the cure.

My Non-Conflict of Interest Statement

For the first 10 years of running this blog, I did not work for a company doing medical research. In 2018, I started working for Bigfoot Biomedical, which is developing an "automated insulin dosing/delivery solution" (what many call an Artificial Pancreas).
I blog on research aimed at curing type-1 diabetes, and I view Bigfoot Biomedical's work as treating type-1 diabetes (not a cure at all). Therefore, I don't view this work as conflicting with my blogging. However, if you consider the kind of automated insulin dosing/delivery solution that Bigfoot is developing to be an actual cure for type-1, then this would conflict with my blogging. I think they are quite different.
I don't get paid in any way by any company working on a cure for type-1 diabetes; I never have. And that includes free samples, free travel, or free anything. I do sometimes participate in market research studies or focus groups, and they sometimes pay.
None of the hours that I have put into my blog, or the posts that I make to any web site, has ever been paid for. (Except for some very nice and heart felt thank-you emails, and those are worth more than money.)
My daughter has type-1 diabetes and participates in clinical trials. I sometimes report on trials that she participates in, but I do not reveal her participation because I consider her medical history to be private.
I sometimes "beta test" new software or devices involved in type-1 diabetes. When I'm blogging about something where I have been given special access, I say so.
In the past I have volunteered with JDRF and The NIIB Project. I currently am a fellow with JDCA. The JDRF and NIIB work was completely unpaid. JDCA has given me equipment that I use to help my blogging, and on one occasion paid for specific consulting work.