Sunday, November 29, 2015

Tauroursodeoxycholic Acid (TUDCA) Starts a Phase-I Trial

Tauroursodeoxycholic Acid (also known as TUDCA or Taurolite) is a chemical found in bile (especially bear bile).  Mouse and rat studies have found that can preserve beta cells, and it is already approved for us in Europe for relatively rare liver diseases.  It is also widely available as a "dietary supplement" in the US.

This study will enroll 20 adult, honeymooning type-1 diabetics.  Half will get the drug, half a placebo.  Treatment will be TUDCA pills each day for a year.  C-peptide levels after a meal are the primary outcome, and will be measured for 18 months.  They will also check liver function, as a safety issue.  They hope to complete the study by December 2018.  This clinical trial is funded by JDRF. (Note that the study is officially phase-II, but I consider it phase-I because of it's size and first-in-type-1 nature.)

This study is recruiting at one site:
    Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave.
    New York, New York, United States, 10032
    Contact: Ellen Greenberg, MA    212-851-5425    emg25@columbia.edu
    Contact: Robin Goland, MD    212-851-5492    rsg2@columbia.edu

Why Test TUDCA? TUDCA has been found to relieve stress in a particular part of the beta cell (called the ER).  The hope is, by lowering this stress, beta cells will not be killed, and either type-1 will not occur, or it will be less severe, or be delayed.  This is based on type-1 diabetes being caused by the following chain of events:
Autoimmune attack  –causes→ ER stress –causes→ Type-1 Diabetes
so if you can stop/lessen/delay the ER stress you can stop/lessen/delay type-1 diabetes.

3 Minute Video: https://vimeo.com/118597801
Information For Patients: http://www.nbdiabetes.org/news/unique-jdrf-funded-clinical-trial-tudca
Press Release and Video: http://jdrf.org/blog/2015/02/09/t1d-trial-looks-to-teach-an-old-drug-new-tricks/
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02218619
Wikipedia entry: https://en.wikipedia.org/wiki/Tauroursodeoxycholic_acid
Earlier News Article: http://www.hsph.harvard.edu/news/press-releases/newly-discovered-mechanism-suggests-novel-approach-to-prevent-type-1-diabetes/


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.

2 comments:

Sergey Veluzam said...

Hi, Joshua.

Just want to thank you for the great job you're doing here, in that blog.

I think the reviews of current researches, which you write here - is a great source of hope for all of us, people with diabetes.
I believe there are people all over the world (I'm from Russia, f.e.), who reads your blog, even though there are not much comments on the posts. That's just a silent gratitude :)

If I'm allowed to ask (may be that's not a correct question though), from your point of view is there some sort of favorites among the current researches, which might become a solution for people, who already live with I-type diabetes for some time? Just curious about your opinion, maybe you see some of them to have more potentials, then others?

Joshua Levy said...

It's a great question. I don't have a great answer, but here are my quick thoughts:

First, I try not to have favorites. My opinions really don't matter. However, it's clear that phase-II clinical trials are closer to actual use than phase-I, so in that way, I prefer phase-II to phase-I. Similarly, I prefer treatments that have already had one successful clinical trial, to those which have not had any, and especially to those which had unsuccessful previous clinical trials.

So with all that in mind, take a look at the Funding Summary which I publish every year in September or October. In 2015 here: http://cureresearch4type1diabetes.blogspot.com/2015/10/jdrf-funding-for-cure-2015.html
Look for the research marked "Established", in phase-II:
* ATG and GCSF by Haller at University of Florida (Established)
* Diabecell by Living Cell Technologies (Established)
* Stem Cell Educator by Zhao (Established)
* BCG by Faustman at MGH (Established)
Unfortunately, none of these are in great shape. ATG/GCSF had small results. Diabecell also had small results. Stem Cell Educator had good results (maybe very good results) in one study, but almost no results in another. BCG was unsuccessful in it's first clinical trial.

Joshua