Saturday, November 5, 2016
Ustekinumab Is Fully Enrolled
Ustekinumab, an immune modulating drug, started a Phase-II? trial in July 2014. I previously blogged about it here:
They completed enrollment on May 24, 2016, which means they should finish gathering data by May 24, 2017, because they need to gather data for a year. Successful results are usually published in less than a year after completion.
This drug was approved in the US in 2009 for treating psoriasis, which is an autoimmune disease (where the immune system self attacks skin cells rather than pancreas cells, as with type-1). It has also been tested on multiple sclerosis, Crohn's disease, and sarcoidosis (also all autoimmune diseases). Ustekinumab is thought to work by blocking inflammation, and specifically blocking two immune molecules called IL-12 and IL-23.
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02117765
In July, A Phase-II? Verapamil Trial Was 20% Enrolled
A research group at the University of Birmingham (Alabama) is testing Verapamil on people in the honeymoon period. The hope is that Verapamil will cause beta cells to naturally regrow. I've previously blogged on this research here:
They have been recruiting for over a year, but have only enrolled 12 people, out of the 52 they need. At this rate, they will not be fully enrolled within 2 years as they had hoped, and that's a problem.
The drug they are testing is already approved (and pretty widely used) for high blood pressure, so it should not be that hard to recruit for this study. However, only adults can be recruited (per FDA rules). Obviously, limiting recruitment to adults still in their honeymoon phase makes this process much more difficult, since most honeymooners are youth, not adults.
Terminated: Leptin by Garg at University of Texas
On June 23, 2015 a Phase-I trial of Leptin being run by Dr. Garg at the University of Texas, was cancelled. The clinical trial record says terminated at the request of the sponsor. Since it was being sponsored by JDRF and by Amylin (which makes Leptin), I assume that Amylin shut down the research. You can read my previous blogging here:
At one time they were going to dose 15 people, but they ended up only dosing 7. It was a Phase-I, pilot study, so there was no control group. The researchers do hope to publish results, and I'll blog on them when they come out.
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT01268644
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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.