Friday, January 22, 2016

Exsulin / Ustekinumab Combo Starts Phase-I Clinical Trial

Exsulin is a drug designed to trigger beta cell growth and Ustekinumab is designed to modulate the immune system.  These researchers are testing them together as a combination cure for type-1 diabetes.

My previous blogging on Exsulin (previously called INGAP) is here:
My previous blogging on Ustekinumab is here:

The Trial

The trial is on 5 people with no control group.  It started in Nov-2015 and will finish in June-2017.  It is open to adults who have had type-1 diabetes between 2 and 10 years, so this is for established type-1 diabetes, not honeymooners.  The people in the trial will get two injections of  Ustekinumab (one month apart) and twelve weeks of daily Exulin injections.

Results will be measured after six months.  The primary outcomes are "safety and tolerability" while the secondary outcomes are various C-peptide measures and one A1c measure.

This trial is recruiting at the Montreal General Hospital (Montreal, Quebec, Canada):
Contact: George M. Tsoukas, MD    514 934-8017
Contact: Louise Ullyatt, RN    514-934-1934 ext 42115


Exsulin (INGAP) is a treatment with a history.  It's gone through two major cycles of clinical trials, and neither one panned out.  The researchers think that this was because Exsulin was stimulating beta cell growth, but these new beta cells were destroyed by the autoimmune attack, so even though the Exsulin was working, it was not benefiting the patients.  They are optimistic that by pairing it with an immune modulator (Ustekinumab), patients will see the benefit.

Obviously, five people is a very small trial.  However, since these are established, adult type-1 diabetics, they should have consistently very low C-peptide numbers.  Any increase should be noticeable and would be important.

It will be interesting  to compare these results to the Ustekinumab honeymoon results.  Honeymoon is a time when the body is still naturally producing enough insulin to make a difference, so comparing Ustekinumab+honeymoon to Ustekinumab+Exsulin will tell us something about Exsulin  (or maybe effective Ustekinumab doses).  The Ustekinumab trial is scheduled to finish in March.  However, that study is still listed as recruiting and needs 20 adult honeymooners (which is a tough recruitment goal). So it might take longer than expected.

News Article:
Press Release:
Clinical Trials:

Joshua Levy 
publicjoshualevy at gmail dot com 
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

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