The good news: DiaPep277 has finished one successful phase-III clinical trial, and is expected to finish enrollment of the second (and last) one in the next few weeks. Once that second one is fully enrolled, there is a two year wait for it to complete, and then (if it is also successful) another year or two for marketing approval, and then (with a lot of luck and good results) DiaPep277 will be generally available in the US. The EU timeline would be similar.
The bad news: The results from their first phase-III clinical trial are no where near a cure. The results so far have been a statistically significant, longer and stronger honeymoon phase. Something like 25% more insulin production in the year after diagnosis.
Discussion: So, if we assume that DiaPep is successful from here on, and gets approved, and works as well in actual use, as it worked in this first phase-III trial, how good is that news?
If you are a glass is half full kind of guy, then you can say things like this: DiaPep is the first treatment that actually changes the path of type-1 diabetes. In addition to lengthening and straightening the honeymoon period, it may result in fewer lows and fewer highs, which means fewer long term complications of the disease. Plus, future research may well make it better than it is now.
If you are a glass is half empty kind of guy, then you can say things like this: DiaPep's impact is only for a year in the honeymoon phase, and it's not even clear that it's good effect will have any impact at all in the long term complications of the disease.
But in any case, I think we are still 4+ years away from general availability.
Zhao in Spain
Drs. Delgado and Otero at Hospital Universitario Central de Asturias (in Spain) are going to start a clinical trial of the Zhao research. (Previous blogging here: http://cureresearch4type1diabetes.blogspot.com/search/label/Zhao) They expect to treat 30 people, and to start in the fall.
News: http://www.hayalternativas.org/noticias/?p=1015 (in Spanish)
Non-Cure Trial to Reduce Hypoglycaemia
I thought this study was interesting, even if it is not aimed at curing type-1 diabetes. The goal here is preserve alpha cell function. Alpha cells are cells in the pancreas that generate various hormones, but not insulin. Almost all of the current research on type-1 diabetes is focused on beta cells (which generate insulin), but type-1 also effects alpha cells. So this research is aimed at trying to preserve the body's natural glucagon response to low blood sugar events.
The news here is that this trial completed enrollment on 7-March-2012, and since it takes 3 months to gather the data, they should have it all by now. So we just need to wait for them to publish the results.
Clinical Trial: http://www.clinicaltrials.gov/ct2/show/NCT01272583
Great Blog (by Riva) on Meter Accuracy
This is a great posting on meter accuracy:
http://www.huffingtonpost.com/riva-greenberg/glucose-meters_b_1624263.html
Compares different meters to each other. Compares the same meter used at different times. Compares household meters to blood lab readings. What more could you want?
Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My blog contains a more complete non-conflict of interest statement.
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/
9 comments:
I suspect a real cure is a long way off. We need to think of every advance as a small step on an upward path. treatment for diabetes has improved in small steps that have led to considerable improvements in lifestyle, and longevity. While we are waiting for a major improvement, lets not overlook the progress that has already been made.
diabeticsurvivalkit.com
Hi Joshua,
Dr Faustman has published her paper. Please review it when you get time. Just fyi.
- pdxmom
Thanks very much. Dr. Faustman's public relations guy emailed me as soon as the paper was available, and I've already printed it out. It is complex, and there is a lot of data there, so I don't expect a quick blog post on it. Also, I had another blog post about 95% ready to go.
So expect a non-BCG posting early next week, and hopefully a posting on Dr. Faustman's paper either late next week, or the week after.
Two of the phrases that I always keep in mind as I write my blog are these:
"Measure twice. Cut once"
"Act in haste. Repent at leisure"
Joshua Levy
Thanks Joshua.. a lot of press from Foxnews to Reuters.. hope there is something there.
Who knows when phase2 results will come..
Maybe Dr.Zhao will speed up his work.. what a waiting game.
pdxmom
Hi!
I love you blog. It makes your readers think rather than just presenting something. Keep up the great work!
Here's something, I just found this "diabetes cured in mice"-article, maybe you'd like to look into it? I would be interested in your thoughts:
http://news.vanderbilt.edu/2012/03/fat-as-diabetes-treatment/
Best wishes
Vera
I learned a great deal from your blog. As my user names implies, my 24 year old son was diagnosed with LADA two years ago. He still has beta cell function. He tested positive for antibodies so it is not a false diagnosis. He is taking low dose naltrexone which we hope will preserve the function he has left. He is taking one shot of slow release insulin a day but he can get by without it if he is very careful with his diet. Do you know of other people using LDN? One person contacted me whose daughter cut her insulin requirements in half when she started LDN. It is not a cure but hopefully it will halt the progression. Thanks for any information you can give me.
Bev
I blogged on LDN a couple of years ago here:
http://cureresearch4type1diabetes.blogspot.com/2010/06/possible-cures-for-type-1-in-news-late.html
There was also this research, which is about eight years old:
http://www.ncbi.nlm.nih.gov/pubmed/14988322
Joshua Levy
As well as I remember when I looked up that study they were using Naltrexone at the regular dose, not low dose. There is no comparison as the effect would be completely different.
It seems research is moving in favor of type one being caused by lack of regulatory T cells. I read in the TREG study, they remove these cells and clone them - then put 1500% more back into the patient. It was curing people but they did not know what, if anything, the long term effects of cloning those cells might have. LDN boosts the production of regulatory T cells 300%.
I am using it for Hashimoto's disease and I am completely off medication. I have always had a low body temperature of 96.8 to 97 degrees. Since starting LDN, my body temperature is normal for the first time in my life - 98.6.
Of course, LDN will not restore what has already been lost. It needs to be started before all the beta cells are destroyed. I wish more people were aware of LDN.
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