Current Research into Cures for Type-1 Diabetes: April 2013

Sunday, April 28, 2013

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

Unfortunately, this is bad news. But here it is:

Canakinumab and Anakinra Both Fail Phase-II Trials in Honeymooners

Canakinumab (brand name Ilaris, previously known as ACZ885) and Anakinra (brand name Kineret) are different drugs, but they have a lot in common. Both target IL-1, which is part of the immune system. Canakinumab is already approved in the US for the treatment of cryopyrin-associated periodic syndromes. Anakinra is already approved in the US for the treatment of rheumatoid arthritis. Unfortunately, both failed Phase-II trials for type-1 diabetes. Here is the quote from the abstract:

Canakinumab and anakinra were safe but were not effective as single immunomodulatory drugs in recent-onset type 1 diabetes.

A previous, smaller test of Anakinra had also failed.

Discussion

I occasionally hear arguments that testing drugs on NOD mice is the wrong approach. That we should not bother to do that, and just go straight to human testing. People who make this argument are quick to point out that NOD mice are commonly cured of type-1 diabetes, but none of these cures have worked in people. They often go a step farther and suggest that maybe NOD mice are so different that they are leading researchers astray. That a successful mice cure means it won't work on people, and conversely that drugs that work on people might not work on mice.

However, both of these drugs were tested initially in people. They were never tested (alone) in NOD mice. And they both failed. Of course, two examples don't prove anything. However it does support the idea that curing type-1 diabetes is tough no matter if you test first in mice or first in people.

Abstracts:

http://www.lancet.com/journals/lancet/article/PIIS0140-6736%2813%2960023-9/abstract

http://www.ncbi.nlm.nih.gov/pubmed/21518168?dopt=Abstract

Clinical Trial Records:

http://clinicaltrials.gov/ct2/show/NCT00947427

http://clinicaltrials.gov/ct2/show/NCT00711503

http://clinicaltrials.gov/ct2/show/NCT00645840

Wikipedia:

http://en.wikipedia.org/wiki/Canakinumab

http://en.wikipedia.org/wiki/Anakinra

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. Thanks to everyone who helps with the blog.
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/

Tuesday, April 16, 2013

Three Months Of New Clinical Trials (end of 2012)

This is a quick summary of all of the new clinical trials into type-1 that started between October 1st, 2012 and January 1st, 2013. These are trials which were entered into the FDA's clinical trial database for the first time during these three months. You can see the database here: www.clinicaltrials.com

Summary table for the last three months in 2012:

48 Total Clinical Trials
-- ----- -------- ------
9 Artificial Pancreas Research into systems that automatically dose based on CGM data.
5 CGM Research into Continuous (ie. Real Time) Glucose Monitoring.
2 Transplantation Research in "classic" transplantation (with immune suppression).
1 Infrastructure Research that helps or speeds up future research.
1 Prevention Research aimed at lowering the number of type-1 diagnosis.
2 Complications Research aimed at preventing or curing type-1 complications.
10 Treatment Research into improved BG control technology.
3 New Test Kits
2 Delivery
5 New Insulin
16 Improved Control Research that lessens the need for BG control technology.
8 drug
4 behavioral
2 nutrient
1 diet
2 Cure Research aimed at curing type-1 diabetes.

So that means that 4% of new clinical trials were targeted at curing type-1 diabetes.
Both clinical trials aimed at curing type-1 were started by LCT, which I've blogged on before:
http://cureresearch4type1diabetes.blogspot.com/search/label/LCT

Below are some of my comments on some of these clinical trials:

Liraglutide (Victoza) is the Biggest Hot Spot
(but as a treatment, not a cure)

Liraglutide is a drug already approved for type-2 diabetes, however recently there has been a lot of interest in it's ability to help type-1 diabetics control their blood glucose levels. Five of the clinical trials started in the last quarter of 2012 were testing Liraglutide on type-1 diabetics, and this is in addition to at least four trials which had previously started.

You can read more about the drug here:
http://en.wikipedia.org/wiki/Liraglutide

And my previous blogging on it here:
http://cureresearch4type1diabetes.blogspot.com/search/label/Liraglutide

Effects of Chromium Supplementation on Type-1 Diabetes

This study apparently started in 2007, but was first registered in late 2012, and they expect to finish in 2013. It will enroll 150 people. They are recruiting patients in the Shreveport, Louisiana, USA area, and it is open to people aged 8-21.

Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01709123

Exsulin (INGAP) Trial is Officially Suspended

Exsulin corporation has officially suspended their phase-II trial of INGAP (also called Exsulin). There has not been any new news or scietific papers listed on their web site for 2 years, so I think this potential cure is pretty near to death.

My Previous Blogging: http://cureresearch4type1diabetes.blogspot.com/search/label/INGAP
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00995540

Pet Fish for Better BG Control

One clinical trial is studying the effects of having a pet fish on blood glucose levels in teenagers. (I'm not making this up, and it's not April 1st!) Half the kids enrolled will get a picture of a fish, the other half will get an actual fish, which they are expected to take care of. A1c levels will be compared. Here is a quote from the researchers:

There is a lack of studies assessing the impact of pet ownership on the health and well-being of adolescents. The process of caring for, loving and being loved by a companion animal could offer direct and/or indirect benefits to the HRQoL [health related quality of life] in children with T1DM. To the investigators' knowledge, there are no studies examining the impact of pet ownership on glycemic control and HRQoL in youth with T1DM.

They are recruiting in Dallas, Texas, USA.

Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01733524

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. Thanks to everyone who helps with the blog.
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/

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.