Results from a phase-I Clinical Trial
Back in Sept 2009, Dr. Garg started a small pilot trial of Sitagliptin and Lansoprazole. These are two drugs currently used for type-2 diabetes, but this trial is aimed at using them on people who have type-1 diabetes. The study was supposed to last about three months, and now they have published some results.
Summary:
The [treatment] lowered their mean blood glucose by about 12 mg/dL and their A1Cs by 0.27%, and they were able to cut their insulin dose by nearly 10 percent during the treatment period.
They are very happy with the results and plan to start a 120 person study. You can see the government clinical trials registration here, although it hasn't started yet:
The improvement looks pretty small to me. They are cheering about 12 BG points improvement? A quarter point A1c? 10% less insulin? So, for example, someone who is currently averages a BG of 150 might drop to 138. An A1c might go from 7.5 to 7.25. Instead of using 60 units of insulin a day, they might use 54. I'm underwhelmed, and I hope they get bigger improvements in their phase-II studies. On the other hand, Lansoprazole is a common antacid and is available over the counter, and while Sitagliptin is prescription, it is also very common. I don't know the longest clinical trial run with either one of these drugs however. I'm a little nervous that previous testing of Lansoprazole (the antacid) might just assume you take it once in a while. I'd be real curious if anyone has seen what happened (even in animals) if you took it every day for a month, a year, 10 years, etc. Since that is what is envisioned here. I expect that is what will be learned from the phase-II and phase-III trials.
As far as this blog is concerned, I don't think I will continue following this research, because I think it looks like a treatment for diabetes, not a cure. But I don't want to be too "down" on this research. Up until now, different types of insulin has been the only treatment available for type-1s, so this might be the first step to having an array of drugs that help keep BGs more stable. I know a lot of people would be very happy with a .75 or 1 unit change in A1c, and as a first test, this got 1/3 to 1/4 of the way there. So maybe further development will get there.
Sources:
http://www.jdrftalk.org/2011/01/19/pilot-study-shows-popular-type-2-diabetes-drug-lowers-blood-sugar-levels-in-people-with-type-1-diabetes/
http://www.renalandurologynews.com/type-2-diabetes-drug-shows-promise-for-type-1/article/193749/
http://www.clinicaltrials.gov/ct2/show/NCT00978796
DiaPep277 Fully Enrolls a Small Phase-III Trial
DiaPep277 is a protein design to help train the body's immune system not to attack it's own beta cells. It was the first treatment that I know of that started phase-III clinical trials, and has been in them for years. There were two different phase-III studies underway, both about 300 people. (Remember that for US or EU approval new treatments generally require two phase-III studies of about this size.) However, the news story below is about a smaller "follow on" phase-III study with 40 people. This study will follow people for 2 years after they were already part of the phase-II study. It is looking at longer term safety/effectiveness issues. Since it is fully enrolled, we "just" need to wait 2+ years for the results. Of course the results from their mainline phase-III trials matter much more.
News: http://www.globes.co.il/serveen/globes/docview.asp?did=1000624744&fid=1725
Clinical trial: http://www.clinicaltrials.gov/ct2/show/NCT01281072
DiaPep277 Fully Enrolls a Small Phase-III Trial
DiaPep277 is a protein design to help train the body's immune system not to attack it's own beta cells. It was the first treatment that I know of that started phase-III clinical trials, and has been in them for years. There were two different phase-III studies underway, both about 300 people. (Remember that for US or EU approval new treatments generally require two phase-III studies of about this size.) However, the news story below is about a smaller "follow on" phase-III study with 40 people. This study will follow people for 2 years after they were already part of the phase-II study. It is looking at longer term safety/effectiveness issues. Since it is fully enrolled, we "just" need to wait 2+ years for the results. Of course the results from their mainline phase-III trials matter much more.
News: http://www.globes.co.il/serveen/globes/docview.asp?did=1000624744&fid=1725
Clinical trial: http://www.clinicaltrials.gov/ct2/show/NCT01281072
Note that both of these guys cite Dr. Faustman's work, but are totally separate from it. One of the "tricks" of scientific scams, is that it helps to cite real research, as part of your fraud. So the fact that Drs. Arnim and Broxmeyer are citing Dr. Faustman says nothing about Dr. Faustman's work.
Ulrich von Arnim
If you ever wanted to know what a type-1 diabetes cure fraud would look like. Here is your chance:
http://bva-tec.com/studien_en.php
And here is the news coverage.
http://www.theage.com.au/national/health-conman-strikes-again-20110209-1an2v.html
I'm not worried that this guy might have really cured type-1 diabetes: he's been in jail for two years for fraud, and has an arrest warrant waiting for him in Germany. But it is interesting to look at his web site. If that was your only source of information, you would think it was real. The only tip-offs that I saw were these:
- If you look at the "clinical trial registration" number column, I can see that those are not European clinical trial numbers. Nor are they American numbers. I think they are European patent numbers (and patents are not the same as clinical trials!) Also the first row that says "(pre-study)" so has no clinical trial number. That's wrong: if they used people, they gotta have a clinical trial. There are ethical and legal issues if they don't. (It's possible that things were different in 1990-1992, but I don't think they were that different.)
- The second issue was the number of people "cured". He claims to have cured about 14,000 people. Now, there are about 1.5 million people with type-1 diabetes in the EU, so he has cured about 1% of them. Already. And we've never heard from even one of his patients. Sounds nuts to me. (And he claims to have cured 1000s of people as long as 20 years ago, and no one has talked about this?)
Lawrence Broxmeyer
This guy has a fringe theory, or maybe a quack theory, that diabetes is caused by Tuberculosis (TB). Actually, he has a lot of theories that a lot of different diseases are caused by TB.
http://lawrencebroxmeyer.wordpress.com/2011/01/26/diabetes-mellitus-tuberculosis-and-the-science-of-denial-by-dr-lawrence-broxmeyer/
If you believe this stuff, then it's obvious why a TB vaccine (like BCG) would cure type-1 diabetes. He conveniently ignores the fact that giving BCG to people with type-1 diabetes does not cure them. Nor does it prevent type-1 diabetes. (In five or six previously completed studies.)
Random Reading / Listening
If you have a CD player in your car, I recommend a recorded lecture called "What is Wrong with Cloning?" by Dr. Arthur Caplan. (The Sunnyvale, California, USA library has a copy.) It is 1/3 a discussion of ethics, 1/3 the science of cloning and stem cells, and 1/3 stand-up comedy. I have never laughed so hard while learning so much. It's published by The Great Lecture Library.
This University PR piece:
http://www.ucsf.edu/news/2011/02/9428/type-1-diabetes-clinical-trials-aim-save-beta-cells-immunotherapies
describes three different clinical trials all being run out of UCSF by Dr. Steve Gitelman.
You can search my blog site for "Gitelman" to see previous coverage of these trials.
You might want to also look at this data, about longer life spans for type-1 diabetics dx recently vs. dx in the 1950s:
http://www.t1diabetes.nih.gov/Research_Accomp.pdf
Reminder About The Blog
This blog generally only covers research results. Occasionally related topics are discussed. However, I generally don't discuss funding issues, stock issues, new hires (such as presidents, new board of director members, etc.) patient issues, etc. These are all news worthy, but they are not the kind of news that I cover here.
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.
Blog: http://cureresearch4type1diabetes.blogspot.com
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