Current Research into Cures for Type-1 Diabetes: March 2014

Monday, March 31, 2014

Possible Cures In The News (March)

Here are some bits and pieces of research, that I found interesting:

GAD65 Not Effective for LADA

GAD65 is one of the molecules targeted in the autoimmune attack which leads to type-1 diabetes. A company called Diamyd, developed it as a honeymoon cure for type-1 diabetes. The hope was it would train the immune system not to attack pancreas cells, and that would stop type-1 diabetes. It looked OK in phase-II trials, but failed phase-III trials a few years ago.

However, there were a few other studies underway when the phase-III data came in, and this is one of those studies. The researchers were giving GAD65 to people who had LADA (Latent Autoimmune Diabetes of Adults). LADA is a not separate form of diabetes, but a name given to people who have type-1 diabetes, but are diagnosed in adulthood (usually over 25).

In this trial, GAD65 treatment had no effect.

Abstract: http://care.diabetesjournals.org/content/early/2014/03/04/dc13-1719.abstract?papetoc

Non-Cure Research

When Does Type-1 Diabetes Start?

Currently, type-1 diabetes is diagnosed when symptoms are seen. Usually, those symptoms are signs of high blood sugar: excessive urination and thirst, unexplained weight loss, lack of energy, etc. More recently, some people have been diagnosed because their after meal blood sugar spikes above 200, even before the other symptoms are seen.

But now, there is some discussion that maybe we should change the definition of type-1 diabetes even earlier. You can read about that in the link below:

JDRF News: http://bayarea.jdrf.org/blog/redefining-diagnosis/

Another Veo Safety Study

The Medtronic Veo is the first (very small) step to an artificial pancreas. It shuts off for a few hours if blood sugar levels go low for too long. This could be a huge step forward in preventing "dead in bed" fatalities, which are a significant cause of death for people with type-1 diabetes.

Anyway, there was a clinical trial to find out what would happen if the Veo cut off insulin incorrectly, when the BG levels were high (instead of low). This is the exact opposite of what the Veo is supposed to do, and it has not been seen to happen in actual use. However, the idea was to test to see what would happen, if the pump failed in this way.

The researchers found that even if this failure occurred, nothing bad happened to the person using it. So that gives an added level of safety for this product (and presumably similar products, when they come to market in the future).

Abstract: http://care.diabetesjournals.org/content/37/3/773.abstract?etoc

Future Postings

I'm currently working on three blog postings, which I hope to get out in the next month, but obviously, I'm way behind, so no promises. And I don't know what order they will come out in:

Dr. Damiano's Bihormonal Artificial Pancreas
Dr. Faustman's Phase-II study of BCG
General Update on AAT

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, JDCA, or Tidepool 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.

Monday, March 3, 2014

Imatinib ("Gleevec" / "Glivec") Finally Starts a Phase-II Clinical Trial

A year ago, researchers (Drs. Gitelman and Bluestone) at UCSF filed the paperwork to start a clinical trial testing Gleevec on people. Now, they can finally start enrolling people in the trial. The generic name for this drug is Imatinib. It is sold as Gleevec in the US and Glivec in most of the world.

Gleevec is a drug already approved for treating cancer. Patients will take a daily pill, will visit the clinic at 2 weeks, then monthly for the first year, and after that twice per year. The researchers will measure C-peptide (to see if patients are generating their own insulin) as well as how much injected insulin the person needs, and their A1c numbers.

I've previously blogged on this trial here:
http://cureresearch4type1diabetes.blogspot.com/2013/02/possible-cures-for-type-1-in-news-mid.html

I also created a "Timeline of Gleevec as a Potential Cure for Type-1 Diabetes" that you can look at. This timeline is experimental, so if you have any suggestions on how to make ti better, please email them to me.

They are hoping to finish collecting data in 2016 and complete the trial by 2018. It is a 66 person trial (44 will get the treatment, 22 will be in the placebo group). But this is a honeymoon trial, only people within 100 days of diagnosis will be included. Imatinib is a relatively new cancer drug, which is popular because it targets an enzyme that only cancer cells have, so it is relatively non-toxic to non-cancer cells. (The buzzword is "targeted".) The obvious question is, why would it be expected to work on type-1 diabetes? It's not clear (at least to me) exactly why Gleevec should stop type-1 diabetes. It does target parts of the immune system and it does lower inflammation, so either one of those (or both) could be it's mechanism of operation. Or, it could be something completely different. The work done in mice suggests that it might be the last option: a completely different mechanism, but there is not enough data to be sure.

Unfortunately, right now, they are only recruiting patients 18 years and older (an FDA limitation). Since this is a honeymoon trial, that is a serious limitation, and will make it hard to find people to recruit. The hope is that after some adults are successfully included in the study (and no safety issues come up), they will be able to lower the recruitment age for future patients, and fill the rest of the trial more quickly.

They are recruiting at several locations:
San Francisco: Contact: Chrinstine Torok, RN 415-502-9089 torokc@peds.ucsf.edu
Denver Contact: Jennifer Smith 303-724-8272 jennifer.e.smith@ucdenver.edu
Indianapolis Contact: Jennifer K Terrell 317-944-2584 jkramey@iu.edu
Omaha Contact: Chris Smith 402-280-4319 christosmith@live.com
Philadelphia Contact: Charles Isaacs 215-590-7222 isaacsc@email.chop.edu

Wikipedia: http://en.wikipedia.org/wiki/Imatinib
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01781975

Orange Book Entry: http://www.accessdata.fda.gov/scripts/cder/ob/docs/temptn.cfm

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, JDCA, or Tidepool 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.

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.