Tuesday, February 5, 2019

How to find a clinical Trial (2019 Update)

The decision to join a clinical trial is a personal one, which I believe is best made between the person with type-1 diabetes (or parents) and their doctor.  However, I know that some type-1s don't have regular endocrinologists, and also some doctors don't tell their patients about available trials.  Therefore, I've put together this blog on how to find clinical trials, so that people with type-1 diabetes, who want to, can find trials to discuss with their medical team.

The web pages discussed below have a wide range of goals, so you will find trials aimed at curing, preventing, and treating type-1 diabetes, and also the complications caused by type-1 diabetes.  These trials also include many different methods: new drugs, new devices, diets, psychological treatments, surgeries, etc.

If you know of any web site useful to finding T1D studies, which is not on this list: please send it to me, so I can add it!

Web Sites That Search For Clinical Trials

JDRF has a good web page to find clinical trails based on age and location: https://www.jdrf.org/research/clinical-trials/
(This tool finds all type-1 diabetes studies, not just those funded by JDRF.)

There is also a blog created by Jennifer Schneider which has a great map to help you find type-1 clinical trials: https://type1trials.blogspot.com/ 
The map by itself is here:
https://www.google.com/maps/d/viewer?mid=1OL5RWPz-D1FiViGpxhAjqEEv2Q2Ck_n3&ll=45.137952951318496%2C-102.69609393571398&z=5

Using This Blog

When I blog about a new clinical trial, I usually link to their recruitment page, and include the names, emails, and phone numbers of the recruiters.  This information is usually with the first posting announcing that they have started recruiting.  I also include a link to the Clinical Trial Registry (often an "NCT" or "ISRCTN" number.  By following this link, you can often find even more information on the trial.  So you can search through this blog to find interesting clinical trials near you.

Other Organizations To Search

If you want to do more searching on your own, then you can check out the following web sites:

https://www.immunetolerance.org/patients/autoimmune-disease
The Immune Tolerance Network (ITN) is a very interesting organization, which I view as part of the "infrastructure" of diabetes research.  They help researchers organize and run clinical trials aimed at stopping autoimmune attack, and similar subjects within the immune system.  They cover research into type-1 diabetes, and also related autoimmune diseases.  At any one time, they usually have a dozen or so studies going on, and a couple are recruiting all the time.

Because ITN runs a network of doctors who cooperate in clinical trials, their trials often recruit at many different sites all over the US (and sometimes the world), so you have more chances to enroll.  Their studies are more likely to be available near you.

The ITN's Home Page: https://www.immunetolerance.org/

Official Clinical Trial Registries

All clinical trials should be registered at some official web site, so these are the largest and most diverse places to look for a study.  In general they contain a lot of information, but are clunky to use. They are more designed for research professionals, than random people looking for a trial.

You can search for phrases like "type-1" and "diabetes" and limit your search to studies that are recruiting right now, and even by location where they are recruiting.   Personally, I've found the JDRF site has the same information and is much easier for a patient or parent to use.  But the FDA site has more info, so if you find a trial using the JDRF site, you can look up the same trial on this site, and learn more about it.

http://www.clinicaltrials.gov
This is the official US FDA registration site for clinical trials.  It covers just about everything in the US, and many trials not done in the US are registered here as well.

http://www.who.int/trialsearch/
This is the United Nations's official registration site for clinical trials which covers the whole world.  Searching here will find trials registered in individual country's registry databases (all the sites listed in this section, plus many more).

https://www.clinicaltrialsregister.eu/ctr-search/search
This is the European Union's official registration site.

http://www.anzctr.org.au/BasicSearch.aspx
Australia and New Zealand

https://upload.umin.ac.jp/cgi-open-bin/ctr_e/index.cgi
Japan's clinical trial registry (in English).

Note: China has a clinical trial registry in English as well, but I could not get it to work:
http://chictr.org.cn/enIndex.aspx

Looking Near You

If you are near a major university or diabetes research center, you might want to "reach out" to them.  I know that UC San Francisco, Stanford, The Barbara Davis center at University of Denver, DRI (in Miami), University of Florida at Gainsville, the Joslin center and Harvard (both in Boston) are all doing multiple studies.

Google can help you find the recruiting web pages for these studies, by searching for the name of the University and following it with "endocrinology clinical trials".

Everyone Is Near The Web

Finally, If you are more a "do it yourself" person you might want to look at the Facebook group "Prevent Autoimmune Disorders".
https://www.facebook.com/groups/preventautoimmunedisorders/
This group is crowd sourcing a test of Vitamin-D and Fish Oils as a preventative.  You can read the information in this group, and decide weather or not to participate.

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 Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. 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.

Saturday, January 26, 2019

Three Months Of New Studies

One way that I find new studies which are aimed at curing type-1 diabetes, is by searching the FDA's Clinical Trial Registry. (Luckily for me, this site even works during a partial government shutdown.) In this posting, I'm going to summarize all of the type-1 studies I found which were first registered from Oct-1 to Dec-31, 2018 and which either were recruiting patients, or had been.  (I'm specifically excluding studies which were registered, but which had not yet started recruiting.)

Out of the 41 studies which started during this time, only three (7%) were focused on curing T1D.  However, I'm summarizing all of them here, to give everyone a feel for all the types of type-1 diabetes research underway, and because some people might be interested in some of the non-cure research.

I divided these studies into 6 broad categories:

1. Treatment (16 Studies)
This section included psychological techniques to improve BG numbers, technology such as apps, training to recover low BG awareness, non-insulin drugs to treat or prevent lows, etc.

2. Technology (10 Studies)
These studies were mostly aimed at closed loops, but also other forms of technology, such as meters.  The most interesting (which I will not be covering) is a triple hormone artificial pancreas: researchers at McGill University are testing an artificial pancreas which doses Insulin, Pramlintide, and Glucagon.  They hope it will remove the need for carb counting.
https://clinicaltrials.gov/ct2/show/NCT03800875

3. Diet (Studies)
Two low carb studies, one on something about buckwheat, and I can't remember the fourth.

4. New Insulin (Studies)
I'm not particularly interested in new types of insulin, and most of these were standard "we hope it is a little better, and a little more expensive, than you get now" type insulin.  However, two of these studies were looking at a weekly use insulin.  Called "Insulin 287", it is a background insulin, similar to Lantus, Levemir, or Tresiba, but designed to be taken once a week.

5. Basic Science (1 Study)
Basic science studies are usually done on animals or in petri dishes, however there is one being started on people.  It is studying TMEM219 also called "TMEM219 death factor" and "Transmembrane Protein 219".  This protein is clearly involved in the death of beta cells, and is sensitive to insulin-related proteins.  There is hope that it is part of the process that kills beta cells to start type-1 diabetes, and therefore if we learn more about it, we can prevent type-1.
https://clinicaltrials.gov/ct2/show/NCT03794739

6. Cure Focused Research (Studies)
Finally, there were three studies which were focused on a cure.  I plan to blog on each one of these separately in the coming weeks, as they are all interesting and worth an individual blog:
MER3101 (an adjuvanated Insulin B Chain vaccine)
https://clinicaltrials.gov/ct2/show/NCT03624062
AG019 and Teplizumab (a mash-up of Proinsulin, IL-10, a monoclonal antibody, and bioengineering)
https://clinicaltrials.gov/ct2/show/NCT03751007
GABA (a dietary supplement)
https://clinicaltrials.gov/ct2/show/NCT03721991


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 Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. 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, January 14, 2019

Ustekinumab Starts A Phase II Clinical Trial Called USTEKID


Ustekinumab was approved in the US in 2009 for treating psoriasis, which is an autoimmune disease (where the immune system self attacks skin cells rather than pancreas cells, as with type-1).  It has also been tested on multiple sclerosis, Crohn's disease, and sarcoidosis (also all autoimmune diseases).  Ustekinumab is thought to work by blocking inflammation, and specifically blocking two immune molecules called IL-12 and IL-23.

The USTEKID Trial

This trial will enroll 72 adolescent (aged 12-18) honeymooners (within 100 days of diagnosis).  2/3s of them will get the drug (an infusion of Ustekinumab) once every two months for almost a year, and the other 1/3 will get a placebo, as a control group.  The study will use C-peptide in response to a meal as a primary end point (measured one year after start of treatment).  There are also a bunch of secondary end points.

The first patient started the trial in Dec-2018 and they hope to finish by Oct-2022.

Web site: https://www.type1diabetesresearch.org.uk/current-trials/
European Clinical Trial Registration: http://www.isrctn.com/ISRCTN14274380
EudraCT number: 2018-000015-24

Sites

Primary contact: Dr Kym Thorne
Floor 2, ILS2, Swansea University Medical School
Swansea, SA2 8PP, United Kingdom
+44 (0)1792 606372     k.thorne@swansea.ac.uk

Participating Locations:
(Note that not all sites are recruiting all ages, and not all have opened as yet.)
  • Royal Aberdeen Children’s Hospital, Westburn Road, Aberdeen, AB25 2ZG
  • Countess of Chester Hospital, Liverpool Road, Chester, CH2 1UL
  • Tayside Children's Hospital, Ninewells Hospital, Dundee, DD1 9SY
  • Royal Devon and Exeter Hospital, Barrack Road, Exeter, EX2 5DW
  • Royal London Hospital (Barts), Whitechapel Road Whitechapel, London, E1 1BB
  • University College Hospital London, 250 Euston Road, London, NW1 2PG
  • University Hospital of Wales, Heath Park, Cardiff, CF14 4XW
  • Noah’s Ark Children’s Hospital of Wales, Heath Park, Cardiff, CF14 4XW
  • Evelina Children’s Hospital, St Thomas' Hospital, Westminster Bridge Road, London , SE1 7EH
  • St James’ Hospital, Beckett Street, Leeds, LS9 7TF

This study is supported by National Institute for Health Research (NIHR) (UK), and is part of the ADDRESS-2 network, which is funded by JDRF.

Other Ustekinumab Studies
You can read my previous blogging on Ustekinumab here:
https://cureresearch4type1diabetes.blogspot.com/search/label/Ustekinumab

Both of these studies have the same warning signal.  Both completed over a year ago, but have not yet published their results.   My experience is that studies which are successful publish quickly, usually within a year of completion, so the fact that these researchers have not yet published is a bad sign.

Ustekinumab and INGAP
A small combination study of Ustekinumab and INGAP started in November 2015 and ended in March 2017, but the results have not yet been published.
https://clinicaltrials.gov/ct2/show/NCT02204397

Phase-I Clinical Trial For Ustekinumab
A 20 person phase-I trial for Ustekinumab started recruiting in March 2015 and finished recruiting in May 2016 and therefore should have completed after May 2017, but the results have not yet been published.
https://clinicaltrials.gov/ct2/show/NCT02117765


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 Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. 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.