Current Research into Cures for Type-1 Diabetes: Sirolimus

Showing posts with label Sirolimus. Show all posts

Friday, September 7, 2012

Possible Cures for Type-1 in the News (early Sept-2012)

Phase-II Trial to Test Intranasal Insulin for Type-1 Prevention

Several different groups are experimenting with using insulin to prevent or cure type-1 diabetes. This is similar to giving people with food allergies the food they are allergic to in tiny doses, gradually building up the dose over years until they are no longer allergic. Because insulin is basically a protein, it gets digested, so you can't take pills of insulin. Different groups are experimenting with different methods of getting insulin into a person, in the hopes that it will result in a cure.

This particular group is using a nasal spray. They want to enroll 120 people, and started back in 2006, but I've not previously blogged on it. They are now hoping to finish in late 2016. Obviously, it's been going on for a long time. Because it is being done in Australia (with it's lower population), I'm sure it is taking them longer than they would like to fully enroll it.

News: http://au.news.yahoo.com/today-tonight/health/article/-/14475192/diabetes-vaccine-trial
Web site: http://www.stopdiabetes.com.au/
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00336674

IL-2 and Sirolimus Fail in Phase-I

This clinical trial failed in phase-I, in a pretty obvious way. Here's the quote from the researchers:

Rapamycin/IL-2 therapy, as given in this phase 1 study, resulted in transient β-cell dysfunction despite an increase in Tregs.

So it hurt the patients (although only temporarily) and did not help them. Plus they threw in this (which should really go in my "Cured in Mice" blog:

Such results highlight the difficulties in translating therapies to the clinic and emphasize the importance of broadly interrogating the immune system to evaluate the effects of therapy.

They sure do!

News: http://medicalxpress.com/news/2012-08-experimental-combo-treatment-worsens-diabetes.html
Abstract: http://diabetes.diabetesjournals.org/content/early/2012/06/15/db12-0049.abstract?sid=2b59c310-a735-4fc8-a3e1-f14f9678c935
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00525889

Phase-I Clinical Trial of IL-2 is Complete

This is the other IL-2 clinical trial. It involves 25 people who have had type-1 for less than 2 years. It is complete, meaning they have gathered all the data needed, but have not yet published the results. Since they were complete in April, if they have a positive result, I would expect publication by April 2013, and if they have a neutral, negative, or hard to interpret result, publication after that.

Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01353833

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/

Monday, December 1, 2008

New Phase-I Clinical Trial: IL-2 and sirolimus

This trial is open to people diagnosed between 3 months and 4 years ago, so it's not a classic "honeymoon only" study, but it is limited. Patients will be given two drugs over a three month period. The hope is to preserve some beta cells. This is a classic phase-I trial, looking only at safety in a small number of patients.

US Government Clinical Trials Record: http://clinicaltrials.gov/ct2/show/NCT00525889 (NCT00525889)
Immune Tolerance Network Trial Record: http://www.immunetolerance.org/studies/a-phase-i-trial-il-2-and-sirolimus-recent-onset-type-1-diabetes-mellitus (ITN018AI)
Info for patients: http://www.benaroyaresearch.org/files/webfm/diabetes/web_il2_rapa_intervention.doc
General info on Sirolimus: http://en.wikipedia.org/wiki/Rapamycin
General info on IL-2: http://en.wikipedia.org/wiki/Interleukin_2

Estimated Enrollment:	10
Study Start Date:	August 2007
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

This study is being done in Seattle Washington, and is sponsored by NIAID.

Joshua

This blog discusses cures and preventatives for type-1 diabetes that are either in human trials or just about to start. Treatments for diabetes are not generally discussed here, unless they can turn into a cure or a preventative. My definition of a cure is this:
1. Blood sugar control without testing and with doctor's visits 4 times a year, or less. Any cure must result in an average lifespan close to normal.
2. Does not require a lifetime of immunsuppressive drugs, so it is not trading one treatment for another. (but a couple of operations, or a short course of drugs is OK)
Obviously, this is my personal definition of a cure; yours may differ.
Because a cure for type-1 diabetes is likely to involve a combination of several different drugs or treatments, I try to follow research into anything which may be an important part of the cure.

My Non-Conflict of Interest Statement

For the first 10 years of running this blog, I did not work for a company doing medical research. In 2018, I started working for Bigfoot Biomedical, which is developing an "automated insulin dosing/delivery solution" (what many call an Artificial Pancreas).
I blog on research aimed at curing type-1 diabetes, and I view Bigfoot Biomedical's work as treating type-1 diabetes (not a cure at all). Therefore, I don't view this work as conflicting with my blogging. However, if you consider the kind of automated insulin dosing/delivery solution that Bigfoot is developing to be an actual cure for type-1, then this would conflict with my blogging. I think they are quite different.
I don't get paid in any way by any company working on a cure for type-1 diabetes; I never have. And that includes free samples, free travel, or free anything. I do sometimes participate in market research studies or focus groups, and they sometimes pay.
None of the hours that I have put into my blog, or the posts that I make to any web site, has ever been paid for. (Except for some very nice and heart felt thank-you emails, and those are worth more than money.)
My daughter has type-1 diabetes and participates in clinical trials. I sometimes report on trials that she participates in, but I do not reveal her participation because I consider her medical history to be private.
I sometimes "beta test" new software or devices involved in type-1 diabetes. When I'm blogging about something where I have been given special access, I say so.
In the past I have volunteered with JDRF and The NIIB Project. I currently am a fellow with JDCA. The JDRF and NIIB work was completely unpaid. JDCA has given me equipment that I use to help my blogging, and on one occasion paid for specific consulting work.