About six months ago, I blogged about three clinical trials which had not yet started, but were expected to start "soon". Now the Rilonacept study is actually starting.
This drug has not previously been tested on type-1 diabetes, but is already approved for other diseases (since 2008 to treat CAPS) under the name Arcalyst. It is currently in use in about 12 phase-II and phase-III clinical trials for several different inflammation based diseases, especially Gout. It is an IL-1 inhibitor, and IL-1 is known to be involved in the destruction of beta cells in people with type-1 diabetes. The hope is that this treatment will result in a longer, stronger honeymoon, and may result in long term improvements in A1c (such improvements might lead to fewer serious complications years or decades down the road). This is the third treatment targeting IL-1 that I'm following. Others include Anakinra and Canakinumab.
The study will enroll 15 patients, all of who will be treated with Rilonacept (no placebo group). To enroll you must be over 16 years old, within 5 years of diagnosis, and still producing some C-peptides (> 0.2 nmol/L) in response to food. These people will be followed for six months, involving five clinic visits, and it is hoped the trial will be complete by June 2012. The treatment is weekly injections (under the skin, like insulin). They will be looking for general safety issues, as well as effectiveness (A1c, C-peptides, and insulin dose). This is NOT a honeymoon only trial, by my definition.
This is being run out of Children's Medical Center (Dallas, Texas, USA):
Principal Investigator: Perrin C White, MD perrin.white@utsouthwestern.edu
If you are interested in participating, send Dr. White some email. Don't worry about your C-peptide production. If you meet the other criteria, they will test for that.
It is interesting to me how much the design of this clinical trial has changed in the last six months. You can compare what I'm writing now, to what I wrote back then:
http://cureresearch4type1diabetes.blogspot.com/2010/06/three-new-treatments-preparing-to-enter.html
to see the differences.
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00962026
Thanks very much to Dr. White for providing information about this trial.
News on the Animas Artificial Pancreas
News article on Animas's Artificial Pancreas. Obviously, I'll be a lot more interested when it actually starts a clinical trial:
http://www.bizjournals.com/philadelphia/print-edition/2011/01/21/artificial-pancreas-awaits-fda.html
Background reading on Artificial Pancreases in General
This paper is a little dry and a little dense, but it gives a good summary update of where we are, and the lead author (Hovorka) is actively involved in AP research:
http://www.touchendocrinology.com/articles/progress-closed-loop-systems-type-1-diabetes-0?page=0%2C0
Reminder About The Blog
I'm not a doctor or research professional of any kind. I can not provide medical advice, because I lack the knowledge. I don't recommend one clinical trial or another. I think that any discussion about participating in a clinical trial must be held between you and your medical team. I know not everyone has a doctor they trust, and I'm sorry about that, but I can't give you advice on which clinical trial you should be part of, or avoid.
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
Web: http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials
To Get as Email Join here: http://groups.google.com/group/type-1-diabetes-clinical-trials-news
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