News from ADA 2018

The American Diabetes Association's Scientific Sessions for 2018 (called ADA2018 with hastag #2018ADA) just ended.  I was not there, but did monitor twitter and other social media to get a feel for what was going on.  As in previous years, it was about 90% type-2 and about 90% treatments (not cures), and of the remaining type-1/cure research, only a little was human trials of the type covered in this blog.

So anyway, here is a huge list of links (mostly links to tweets) which I found interesting for one reason or other.  I've tried to categorize them, and in a few cases, after the link, I've added a sentence or two about why I found them interesting.

Summary web sites:
https://beyondtype1.org/breaking-news-from-ada2018/
https://www.healio.com/endocrinology/meeting-news/ada-conference
https://www.diabetesdaily.com/blog/clinical-trials-in-type-1-diabetes-ada-2018-580153/
https://www.medscape.com/viewcollection/34397
http://www.mdmag.com/conference-coverage/ada-2018

Cure Related
ATG/GCSF:
    https://twitter.com/BeyondType1/status/1011252403079745536
    https://twitter.com/Judithendo/status/1011240300742893568
Meta-Dopa, which I need to blog about:
    https://twitter.com/Judithendo/status/1011291591875743744
Encapsulation for beta cells (animals, I think):
    https://twitter.com/Cristob_Morales/status/1011230794831089667

Smart Insulin:
https://twitter.com/mbotana/status/1010599897987473410
https://pubs.acs.org/doi/abs/10.1021/acsnano.7b08152

ViaCyte:
https://twitter.com/ViaCyte/status/1010508277766082560
https://twitter.com/ViaCyte/status/1010493177273442304
https://viacyte.com/archives/press-releases/two-year-data-from-viacytes-step-one-clinical-trial-presented-at-ada-2018

Artificial Pancreas:
There were lots more, but these really called out to me.
https://twitter.com/danamlewis/status/1010527143938416641
https://openaps.org/2018/06/23/detecting-insulin-sensitivity-changes-for-individuals-with-type-1-diabetes-with-autosensitivity-from-openaps-poster-presented-at-american-diabetes-association-scientific-sessions-2018ada/
https://www.healio.com/endocrinology/diabetes/news/online/%7B904dc31d-db81-47e7-9a82-c183e2aca8c4%7D/6-month-implantable-cgm-safe-accurate-in-teens-adults

General Interest:
https://twitter.com/em_saidwhat/status/1010513691056451584
Pregnancy: https://twitter.com/RenzaS/status/1010494620512473088
Average A1c by age: https://twitter.com/RenzaS/status/1010476210088886272
Vit D: https://twitter.com/cristinatejerap/status/1010589989678305280
T2D delays T1D? https://twitter.com/cristinatejerap/status/1010604154186817537
Mice vs. Humans: https://twitter.com/Cell_Onion/status/1010543301580279808
Gut not important? https://twitter.com/DrKirstieBell/status/1010618697440989184
Patch Pump: https://www.healio.com/endocrinology/diabetes/news/online/%7B8540d455-ebc8-4e78-a1dc-f4440bc9cf18%7D/investigational-patch-pump-artificial-pancreas-safe-effective-under-free-living-conditions
Half Units Matter: https://twitter.com/Diabetes_Videos/status/1011391416889696256
Adjunct Therapy: https://www.boehringer-ingelheim.com/press-release/type-1-diabetes?
Bariatric Surgery T1D: https://twitter.com/Ali_Aminian_MD/status/1011647953667272704
SGLT:
    https://twitter.com/MarkHarmel/status/1011646768776392705
    https://twitter.com/AmDiabetesAssn/status/1010860753589587968
    https://www.healio.com/news/online/%7B943b8bde-157a-4d87-ae3c-5f1f1d2fe2d5%7D/dual-sglt-inhibitor-boosts-insulin-efficacy-in-type-1-diabetes

New Patch Pump: https://twitter.com/SanofiDCV/status/1011617549174353920

Type-2:
Lots of comorbid conditions: https://twitter.com/AstraZenecaUS/status/1010526644656799744

Transplants:
https://twitter.com/drpratikc/status/1011353557013073920
An attempt at a head-to-head comparison of islet transplants vs. Artificial Pancreas results.  Interesting!

The other form of bihormonal AP:
https://twitter.com/EndocrineToday/status/1011330691009658880
Most bihormonal AP research uses insulin and glucagon, but this one uses insulin and pramlintide.

Faustman:
News: https://www.healthline.com/diabetesmine/denise-faustman-research-pushback-ada-jdrf?platform=hootsuite
Discussion: https://twitter.com/Drbeth_/status/1010431411671748608
Poster and Discussion: https://twitter.com/HangryPancreas/status/1011294476260831233
ADA and JDCA joint letter (later supported by the Berrie Center):
    https://twitter.com/keddy_moise/status/1011420460612030464
    https://twitter.com/DiabetesMine/status/1011400346441220096
    https://twitter.com/JDRF/status/1011399303665995776
    https://twitter.com/nbdiabetes/status/1011640607259930625
These two guys (and many others) report dropping A1c, but no one calls them a cure:
    https://twitter.com/snp_io/status/1010616966523088896
    https://twitter.com/Fallabel/status/1011280750967246848

Interesting to me:
Open Data Tools for Software Nerds: https://twitter.com/stales/status/1010599135576231936
I found the next tweet interesting because Cure was in title, but treatment in contents.  To me that shows a problem with "cure" research.  Much of it is not really aimed at a cure:
https://twitter.com/DanielJDrucker/status/1010870015183278080
TEDDY:
    https://twitter.com/cristinatejerap/status/1010586167102922752
    https://twitter.com/ERobertson02/status/1010614817244286976
    https://www.healio.com/endocrinology/diabetes/news/online/%7B78982aaa-a6f8-4b1f-a74b-04e3bc6e760a%7D/insights-from-teddy-study-provide-clues-to-islet-autoimmunity-in-children

Low Carb:
https://twitter.com/DikemanDave/status/1011393166849728512
https://twitter.com/JPMcCarter/status/1011328194115522560
https://www.diabetesdaily.com/blog/very-low-carbohydrate-diets-for-diabetes-ada-2018-580309/?utm_campaign=coschedule&utm_source=twitter&utm_medium=diabetesdaily&utm_content=Very%20Low%20Carbohydrate%20Diets%20for%20Diabetes%20(ADA%202018)
https://twitter.com/JPMcCarter/status/1011697843260837888
https://www.linkedin.com/feed/update/urn:li:activity:6417463469972430848/

Atkinson honored (nPOD and much more):
https://twitter.com/_HealthMyself/status/1011262077191716864
https://twitter.com/HIRN_CC/status/1011255219202633728

The "Most Obvious Research Conclusion Award"
https://twitter.com/DrKirstieBell/status/1010881942974291968

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.

Alpha Difluoromethylornithine (DFMO) Starts A Phase-II? Trial in Honeymoon Type-1 Diabetics

This trial started recruiting in April 2015, but I missed it at that time, so I'm blogging about it now.

Alpha Difluoromethylornithine (DFMO) is approved for two quite different issues.  The first is to remove/prevent facial hair in women, while the second is to treat sleeping sickness.  Neither of these are related to type-1 diabetes.   However, this drug was effective in lowering diabetes rates in NOD mice (which are predisposed to an autoimmune diabetes, similar to human type-1 diabetes), and that is what motivated this trial.

The Trial

This trial is recruiting people 12-40 years old, who have been diagnosed with type-1 diabetes in the last 2-8 months.  People will be divided up into 4 different groups, each getting a different dose.  Within each dose group, there will be 6 people who get the treatment and 3 people who get a placebo (and will be a control group).

Primary endpoints are safety related, while other endpoints (such as C-peptide) are targeted at seeing if it works.

The researchers hope to finish gathering data in Dec 2019, so publication should be some time in 2020.  (Although the primary outcome data will be collected in Dec 2018, so there is the possibility of partial results in 2019.)

This trial is being run in three locations:

Riley Hospital for Children: Indianapolis, Indiana, United States, 46202
Contact: Stephanie Woerner, FNP    317-944-2573    sestein@iu.edu 

Women and Children's Hospital of Buffalo: Buffalo, New York, United States, 14222
Contact: Michelle Ecker, RD, CDN, CDE    716-878-7609    mecker@upa.chob.edu 
       
Children's Hospital of Wisconsin: Wauwatosa, Wisconsin, United States, 53226
Contact: Joanna Kramer, CCRC    414-955-8486    jkramer@mcw.edu 


Discussion

Although listed as a Phase-I trial, in some ways it is more like a phase-II study, which is why I've listed it as a Phase-II? study.  The question mark signifies that this drug has never been tested on people with type-1 diabetes before.  I consider it Phase-II because it is the right size (42 people) and the right purpose (testing multiple different doses) to be a Phase-II study.

Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02384889
Results in mice: https://www.ncbi.nlm.nih.gov/pubmed/23846959

Personal Note

I am always surprised how much researching type-1 diabetes teaches me about other subjects.  One part of the story of DFMO is both fascinating and horrifying.  After being developed in the 1990s, it was used intravenously as a treatment for sleeping sickness.  However, in 1995 production was discontinued, because saving lives in Africa was not profitable. Various non-profits lobbied the producer (a big pharma firm) to restart production, but to no avail.  Meanwhile, researchers discovered that it "cured" facial hair in women.  The cream used to do this went into production in 2000, and has been on the market since then.   Under intense pressure from the World Health Organization and non profits, the big pharma company eventually agreed to provide the drug for free to non-profits for distribution to African sleeping sickness patients, starting in 2001.  My best guess is that the lack of drug between about 1995 and 2001 killed between 40,000 and 110,00 people (very roughly).

The key moment in making the drug available may well have been a "60 Minutes" episode.  This is an American weekly news show.  It showed patients dying of sleeping sickness, or enduring painful IV treatments, which was the best non-DFMO drug available, and then followed it up with DFMO's American TV add for removing facial hair.  The juxtaposition highlighted the money-at-the-cost-of-lives reality of the situation.

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.

GNbAC1 Starts A Phase-II? Trial

GNbAC1 is a monoclonal antibody which has completed phase-II testing for treating Multiple Sclerosis, which (like type-1) is an autoimmune disease.  GNbAC1 was developed by GeNeuro SA, a Swiss company, but is being tested in Australia.   They have partnered with Servier, a large French pharma company to do the phase-III trials required to bring it to the Multiple Sclerosis market.

A monoclonal antibody is an artificially created antibody which targets one very specific type of cell in the body.  Different monoclonal antibodies target different types of cells.  So if a disease is caused by a problem in one type of cell, then using a monoclonal antibody to target that type of cell is a promising treatment.  Because several monoclonal antibodies have been successful in treating other autoimmune diseases, they are an active area of research for curing type-1 diabetes.

Previously, GNbAC1 has been tested in four clinical trials as part of the Multiple Sclerosis development program, so its safety is well established (for an investigational drug).  However, since this is the first trial aimed at type-1 diabetes, I'm calling it a "Phase-II?" trial.  (The question mark meaning "no previous testing on people with type-1".)

This Study

This study has enrolled 60 people who were diagnosed with type-1 diabetes within the last 4 year.  The first part will be double blind, with 2/3s getting the treatment and 1/3 not.  After that will be a second, optional part which is not blinded (everyone will get the treatment).  Unfortunately, the primary end point for this trial is safety related.  But their press release does say that they will track various effectiveness outcomes as well (for example: C-peptide and insulin consumption).  The drug will be given as an IV drip once a month (six doses in each part of the study).  People in the study will be followed for about a year.

This study completed enrollment in January 2018, and GeNeuro plans to publish the results from the first part of the trial in September 2018, and the second part of the trial in the first half of 2019.  That is pretty quick!

Press Release: http://www.geneuro.com/data/news/GeNeuro-TD1-Study-Enrollment-Complete.pdf
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT03179423
Company: http://www.geneuro.com/
General Background News Article: http://www.biotuesdays.com/features/2017/11/16/geneuro-pioneering-hervs-against-neurodegenerative-and-autoimmune-diseasess

MS research:
● http://www.msdiscovery.org/research-resources/drug-pipeline/10103-gnbac1
● https://www.ncbi.nlm.nih.gov/pubmed/25392325

Background and Rational

This clinical trial has a very different rational, as compared to previous attempts to cure type-1 with monoclonal antibodies.  In the past, these antibodies have been used to target one of the defective cell types within the immune system.  The idea is to find an immune cell which is involved in the attack on the beta cells, and kill off those immune cells.  That idea has led to some progress, some suggestive results, but nothing like a cure.

These researchers have a different idea.  They note that part of the human genome contains HERVs, which are the remains of retroviral DNA which merged into our DNA millions of years ago.  The researchers believe that while this DNA does nothing most of the time, infection can sometimes cause one of these HERVs (called "pHERV-W") to activate and generate a protein (called "pHERV-W env") used by the retrovirus the DNA came from originally.  Even after the infection, the HERV DNA stays activated.  The pHERV-W env, in turn, causes autoimmune diseases.  If true, this would explain how viral infections can "trigger" type-1 diabetes.

These researchers believe that by using a monoclonal antibody to target pHERV-W, they can stop this process.   So while previous attempts to use monoclonal antibodies targeted malfunctioning immune cells, this attempt is targeting HERV DNA which (according to this theory) is the root cause of the autoimmunity.

Background reading: https://en.wikipedia.org/wiki/Endogenous_retrovirus


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.

Results from a Phase-II ATG and GCSF Combination Trial

I'm embarrassed about this blog posting, because it is very late.  It reports on news announced about 18 months ago.  I was digging through some old emails, and found it.

ATG is Anti-Thymocyte Globulin, a biological agent used to lower immune reactions.
GCSF is Granulocyte Colony-Stimulating Factor, a biological agent which causes bone marrow to generate more stem cells and more immune cells, and put them into the blood stream.

So the two of them together could make an effective combination therapy against type-1 diabetes. ATG would lower the autoimmune attack, and GCSF would help the body regrow beta cells. At least, that is the hope. I wrote about the start of this trial here, and it contains a lot of background material:
https://cureresearch4type1diabetes.blogspot.com/2010/08/atg-gcsf-starts-phase-i-clinical-trial.html

In brief: this study took 25 people, 2/3s got the treatment, and 1/3 got a placebo.  The treatment was spread out over 12 weeks.  The primary result was C-peptide results after 1 year, but this paper reported on extended results after 2 years.

Results from a Phase-II ATG and GCSF Combination Trial

The following graph is from the paper, and you can see that for the first year the treated group did noticeably better.  (Meaning they generated the same C-peptide at the end as at the beginning, while the placebo group dropped over time.)  The 3 to 6 month time period was particularly strong, with the treatment group generating more C-peptide while the control group generated less.  The first year change was statistically significant.  However, during the second year, C-peptide numbers continued to drop for both the treated and placebo groups, and the separation between the two of them shrunk, so that the difference was not statistically significant.

Research Paper:
http://diabetes.diabetesjournals.org/content/65/12/3765?etoc
http://diabetes.diabetesjournals.org/content/early/2016/09/26/db16-0823?papetoc

Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT01106157

Discussion

This is one of several studies which preserved beta cell function for a year during the honeymoon.  Early on, these studies gave me a lot of hope that they could be improved on, and eventually even lead to a cure.  However, so far I haven't seen any movement in that direction.  Treatments that preserved beta cells for one year, have (so far) not been extended to last longer.

Earlier results from this trial were strong enough so that this team started a follow on trial for honeymoon type-1s (people in their first 4 months after diagnosis):
Recruiting Site: http://www.diabetestrialnet.org/ATG-GCSF/index.htm
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02215200

There are two obvious questions in this research:
1. If this treatment were started prior to diagnosis (in people who had several autoantibodies, for example, but were not showing any symptoms of type-1 diabetes), would it prevent the onset of symptoms?
2. If this treatment were repeated on a yearly, or every two year basis, could it prevent type-1 diabetes completely?  And would the hassle and side effects of the retreating on a regular basis be worth it?

Unfortunately, the new study (in honeymooners) will not answer these questions.  But it is three times as large, so it will confirm that this study was not a fluke, and the results should be available very soon.  Recruiting was completed before July 2016, so primary data should have been collected by July 2017, and publication should be imminent.

Since this study started, there is now a new hope for this level of result ("preserving beta cells for one year").  Those results could be applied to presymptomatics: people who had two or more autoantibodies, but no symptoms of type-1.  Preserving beta cells for these people would have the effect of delaying the diagnosis of type-1 diabetes.  That would be great.  However, identifying presymptomatics to test this on has just happened in the last few years, and few studies have looked into this.  But I will be looking forward to seeing the results of these studies (as prevention).

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.

250 Postings And Changes At Work

Last week's blog posting was my 250th blog posting on Current Research into Cures for Type-1 Diabetes!  Also, this year marks the 10th year of publishing the blog, as the first posting was in June 2008  (although I had created a precursor web page in 2006).

Changes At Work

In March I was laid off from my job as a software developer, so I took advantage of the impending job search to think about what I really wanted to do.  And I decided that what I really wanted was to use my software engineering skills to help the day-to-day lives of people with type-1 diabetes.

I limited my job search to companies that were working directly to make the lives of people with type-1 diabetes easier or better in some way.  I'm lucky to live and work in Silicon Valley, so there are several such companies (and non-profits) in the area.  I'm happy to say that starting in late April, I'll be starting as a "Staff Software Developer in Test" for Bigfoot Biomedical.

Several things attracted me to Bigfoot.  First, they are developing an Artificial Pancreas ("automated insulin dosing and delivery solution"), and I'm absolutely convinced that is the quickest path to better treatment, fewer complications, and an easier life for people who need insulin.  Second, their larger goal is to lower the overall burden of type-1 diabetes.   (Not just create a device that is technically better than the competition's, but to create a whole infrastructure of treatment, supplies, and support that is smooth and easy to use.)  Third, their internal software development infrastructure is cool.  It is what I'd expect from a Silicon Valley start up.

So what does this mean for the blog?

I'm not expecting any changes in the blog.  I stopped blogging on artificial pancreas research years ago, so there is no direct conflict of interest.  I won't be blogging on Bigfoot products or the products of competitors.  On the other hand, I will continue to blog about "current research aimed at curing type-1 diabetes" just as I always have.  For me, Artificial Pancreas type devices are treatments and I blog on cures, so there isn't any overlap.

I've already discussed the blog with the Bigfoot team (many are avid readers), and they are very supportive.  Bigfoot wants it's employees active in the type-1 world, and so being supportive of my blog fits into their general philosophy.

How You Can Help This Blog

There are three ways you can help this blog:

• Tell someone about it.  I have zero budget for anything, and that includes publicity, so if you like this blog, the best way to help is to tell other people affected by type-1 about the blog.  If every reader, even just once a year, would tell one person affected by type-1 diabetes about this blog, it would reach 1000s of new readers.  And it doesn't matter if you verbally tell one person, tweet/facebook once, post to a forum or group, or send one email to one person.  It all helps.
• If you read about research aimed at curing type-1 diabetes, which has not been discussed in the blog, then please tell me about it.  My email is below.
• If you have questions about any blog posting or any research aimed at curing type-1 diabetes, please email your questions, or post them as comments to the blog.  These questions tell me what you care about, and they also tell me where I need to spend more time, so they are very helpful to making the blog better in the long term.

Thanks very much for all your support over all these years of blogging.

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.

Stem Cell Educator Starts Two Phase-II Trials

The Stem Cell Educator (SCE) is an attempt to cure established type-1 diabetes by exposing a patient's immune cells to umbilical stem cells, and then returning the cells back to the patient.  Each person had a blood draw, and then a particular kind of immune cell was separated from the blood and specially processed.  The processing phase uses umbilical cord stem cells previously donated by a third party.  The patient's own "educated" immune cells were then returned to the patient.  The stem cells did not go into the person; they were only used for the external processing.

In the last six months, two new studies have started, which I blog on below.  The first is in New Jersey and the second Beijing.

The New Jersey Clinical Trial (NCT02624804)

This study will enroll 10 people.  Everyone will be treated (no control group, no blinding).
The end points are mostly safety related, but there will be some efficiency related end points as well.  There is no mention of collecting efficiency data (such as C-peptide numbers, A1c data, blood glucose, insulin usage, etc.)

This study has started recruiting.  There was hope it would start in mid 2017, but the study needed some lab infrastructure which the medical center did not have at that time, hence the delay while the new labs were set up.

Recruiting at one site: Hackensack University Medical Center
    Hackensack, New Jersey, United States, 07601
    Contact: Mariefel Vendivil    551-996-5828    Mariefel.Vendivil@HackensackMeridian.org 
    Contact: Andrea Ortega    551-996-3923    Andre.Ortega@HackensackMeridian.org 

Clinical Trial Records: https://clinicaltrials.gov/ct2/show/NCT02624804
But note that this clinical trial record is out of date.  The study has not yet started recruiting, no efficiency end points are listed, and the completion dates are too short.

The Beijing Clinical Trial (NCT03390231)

This study will enroll 100 people.  Everyone will be treated (no control group, no blinding).
The primary end point will measure specific immune cells (which are involved in type-1 diabetes) one month after treatment.  Secondary end points will cover insulin sensitivity after a month, and A1c, blood glucose, and c-peptide measurements after three months.

They started in Nov-2017, and hope to finish in either July-2018 or Dec-2020 (see discussion below).

Recruiting at one site: Department of Endocrinology, Chinese PLA General Hospital
    Beijing, China, 100853
    Contact: Yu Cheng, MD,PhD    86 10 55499301    chengyu_301@163.com 
    Contact: Yiming Mu, MD,PhD    86 10 55499301    muyiming@301hospital.com.cn 

Clinical Trial Records: https://clinicaltrials.gov/ct2/show/NCT03390231

Discussion

Differing Results: This treatment has been previously tested twice before.  One of these clinical trials had strong results, but the other one had very weak results.  I've blogged on these in the past:
http://cureresearch4type1diabetes.blogspot.com/search/label/Stem%20Cell%20Educator

The researchers believe they understand why the two trials had different results, and are hoping to apply this knowledge to the current two trials, in order to get better results.

Date confusion: The FDA's clinical trial registration page requires researchers to list three dates for a clinical trial: start date, primary completion, and study completion.  (Once the trial starts, the first is known, while the second two are estimated.)  The primary completion date is when the last data for the primary outcome will be gathered.  The study completion date is when the last data for the study will be gathered.

For the Beijing study, the primary completion date is May-2018 and the study completion date is Dec-2020.  However, the primary end point is a month after treatment, while the secondary end points are either one or three months after treatment.  So that means the study completion date should be two months after the primary completion date, not 2 1/2 years!  My guess is that there are some two year end points as well, which are not listed in the clinical trial registry.   (The New Jersey trial also has two year end points which are not listed in the registry database.)

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.

Possible Cures for Type-1 in the News (March)

This posting is a collection of small updates.

Verapamil's Phase-II? Trial Completes Enrollment

Verapamil is a drug which has been used in the US since 1982 for high blood pressure, migraines, and heart problems.  It also lowers levels of a protein called TXNIP.  The researchers running this trial believe this is important because they believe TXNIP kills beta cells as part of the onset of type-1 diabetes.  So giving Verapamil should lower TXNIP which should improve beta cell survival, and stop type-1 diabetes.  In addition TXNIP is known to lower inflammation, and that might have an effect on type-1 diabetes as well. TXNIP worked in mice trials.

The news here is that they have completed enrollment.  There is good and bad news in that.  The good news is we now know that the trial will finish in 2019, since they completed enrollment in Jan 2018 and need to gather data for a year.  The bad news is that they only recruited 32 people; they were hoping for 52.

Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02372253

Vitamin D Didn't Impact The Honeymoon In A Phase-I Trial

Vitamin D has been a hot topic for the last few years, and there are several different clinical trials looking at it in three different contexts: Does low Vitamin D help trigger type-1?  Does increasing Vitamin D help prevent type-1?  And, does increasing Vitamin D to people who have type-1, help treat or cure it?   All together, there are 15 completed trials, 6 recruiting, and 2 underway but not recruiting, and one not yet started.  That is strong interest.

This trial was a phase-I, honeymoon trial of 36 people.  Half got Vitamin D, and half got a placebo.  The patients who got Vitamin D did do a little better (used less insulin during their honeymoon), but the effect was not statistically significant.

Press Release: http://www.nationwidechildrens.org/medical-professional-publications/vitamin-d-and-the-honeymoon-period-of-type-1-diabetes?contentid=146302
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT01724190

Diamyd and Vitamin D start a phase-II Trial (DIAGNODE-2)

This clinical trial will test a Diamyd injection and oral Vitamin D in honeymoon type-1 diabetes.

It is recruiting in several European countries: Czechia, Spain, and Sweden.  See the clinical trial record for a list of exact sites, there are many in each country.

Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT03345004

Discussion

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

Diamyd has been tested for over 10 years.  All previous trials (which have completed) have been unsuccessful.  There are currently two other Diamyd and Vitamin D trials underway.  While I'm always hopeful that these tests will be successful, Diamyd's long history without success does not give me much to hope for with this trial.


How well can you predict the outcome of clinical trials? Not as well as you may think.

One of the guiding quotes of this blog is "Opinions are not important; but what is important is the reasoning behind them, the data and information they are built on, etc. In short: why a person has opinions is more important than the opinions themselves. And that includes my opinions. Especially "my opinions."  This is a news article on researcher's ability to predict the outcome of studies in their field.  I thought it was interesting reading:
https://www.statnews.com/2018/01/22/clinical-trials-forecasting-outcomes/

A Stock Market Opinion: Diabetes Clinical Trials to Watch

This is a finance/stock analysis of what's important in 2018:
https://www.gurufocus.com/news/622818/three-diabetes-clinical-trials-to-watch-in-2018
From my point of view, they are all type-2 focused (which makes sense from a market share point of view: type-2 is 90% of the market).

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.