Diamyd Combo Phase-II Trial Scaled Back

Back in Feburary 2009 I blogged on a very promising clinical trail that was combining the Diamyd treatment to stop the autoimmune attack and two drugs which were already approved for use in the USA.  This is an update for that research.

Diamyd Combo Phase-II Trial Scaled Back 


This Phase II study combines regenerative agents (lansoprazole and sitagliptin) and Diamyd. The regenerative agents are both marketed drugs in the US.  Diamyd is a vaccine like drug which trains the body's autoimmune system not to attack it's own cells.  Sitagliptin (Januvia) is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and is used for type-2 diabetes.  Lansoprazole (Prevacid) is a proton-pump inhibitor (PPI) which prevents the stomach from producing gastric acid. The researchers hope that both lansoprazole and sitagliptin will help reverse beta cell damage or develop new beta cells.

This trial has been scaled back is a big way.  Originally, the researchers were hoping to screen about 160 people and include about 80 of them in the trial.  However, just after the study enrolled it's first patient, there was a major funding cut at NIH (the part of the US government were the study was being done).  At the same time, the primary investigator (Dr. David Harlan) got a new job at UMass at Worster, and so left NIH.  This double setback caused the study to shrink and be redesigned.  

Instead of 80 people in a placebo controlled, randomized trial, they ended up with 3 people in a pilot study where everyone was treated (so no control group).  Now the good news is that the trial is fully enrolled, so they will have all their data by October 2012.  However, the bad news is that the results will be hard to interpret (maybe impossible).  Because this study is using honeymoon type-1 diabetics, there is natural fluctuation in the amount of insulin used.   So with only 3 people and no control group, it will be hard to tell if any improvements are caused by the treatment or random fluctuation during the honeymoon.


Some Personal Opinions


Obviously, I'm hopeful that Dr. Harlan will restart this experiment once he gets settled at UMass Worster.  As far as I know this is the only clinical trail combining a treatment to control the autoimmune attack and a treatment to help the body generate more insulin.  I think combination like this represent one very promising approach to a future cure to type-1 diabetes. It's very disappointing to have it scaled back so much, and for reasons so unrelated to safety or effectiveness.

Clinical Trials site: http://www.clinicaltrials.gov/ct2/show/NCT00837759
NIH page: http://clinicalstudies.info.nih.gov/detail/B_2009-DK-0056.html
Unofficial Diamyd blog: http://diamyd.blogspot.com/

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.