Comment

Comment by Hockey Mom on March 18, 2011 at 12:15pm

My son was in one of the studies and while the drug did not meet the goal of the study to maintain A1C under a certain level, my son has needed much less basal insulin than control patients and other patients of his size and age in the practice. At one and a half years after diagnosis, we are continuing to reduce his basal doses instead of increasing them. We do not think, however, that he will ever regenerate enough beta cells to discontinue insulin supplementation. This study was never promised to be a "CURE", just a step in the research process.

This is a hard study population because of their age - mostly preadolescent and adolescent children - because the study was not open to younger "just diagnosed" patients. A good A1C still depends upon testing, accurately counting carbs and taking insulin as required whether you have 50% beta cells or 0% beta cells - the amounts of insulin and ratios just are less. Throw in a few hormones and growth spurts and it is hard to maintain a low A1C level. I'm sure there were kids in the control group that did not get the drug that were able to maintain that level because of vigilant parents and there were people like my son(who we are sure got the drug due to his reaction to the drug) that did not maintain the A1C level due to his sport highs and adolescent lapses in judgement.

I hope that they will rewrite the study hypothesis eliminating the A1C factor and focusing only on the beta cell preservation based on 5 hour glucose tests and peptide levels because I still think the drugs have promise. However, for FDA approval of these drugs, the study results must prove your theory. I think what they have proved is that more beta cells does not necessarily guarantee a lower A1C - as long as you have to supplement with insulin manually, there is always room for error and miscalculation. We won't know until much later if the insulin production preserved will protect this group of kids from side effects of the disease.

Comment by Bill on March 18, 2011 at 4:17am

A number of companies have been investigating whether interfering with the immune mechanisms that destroy the insulin-producing beta cells of the pancreas early in the development of the disease can positively affect the course of type 1 diabetes. Last October Macrogenics, working with Lilly, announced that their study of the drug Teplizumab did not meet its primary efficacy endpoint - i.e. the drug did not work in the population studied. Ongoing studies of Teplizumab were discontinued. Just last week, Tolerx, working with Glaxo Smith Kline announced that the Defend-1 study of otelixizumab also did not meet its primary endpoint in type 1 diabetes. These studies were both looking at newly diagnosed type 1 diabetics - not people with longstanding disease. The question being asked in both cases was whether early intervention could preserve the function of the beta cells and either slow or stop the progress of the disease. Unfortunately neither of these drugs was able to demonstrate that they could do so, in spite of earlier promising data.

There are two other ongoing studies that might be of interest to people with newly diagnosed type 1 diabetes. Diamyd is conducting the DiaPrevent study - a study of their drug rhGAD65. This is a vaccine aimed at inducing tolerance to glutamic acid decarboxylase (GAD) and intervening in the immune process and ultimately preserving beta cell function. There are two ongoing studies, one in the US and one in Europe, but I do not believe that either of these is recruiting new patients.

The one trial that is ongoing is that of DiaPep 277 from Andromeda Biotechnology. This is a study of a drug with a new and different mechanism of action than has been studied before. The phase 3 trial is ongoing in the US and Canada. It is recruiting patients who are within 6 months of their diagnosis of type 1 diabetes. Information on the trial, as well as clinical trial sites are listed at www.clinicaltrials.gov. Simply search for Andromeda or type in NCT01103284 in the search box.

Comment by Robert Miles on March 18, 2011 at 1:30am

Meg - this one is in Massachusetts, but not accepting volunteers yet:

http://www.faustmanlab.org/

Doesn't use pumps.

Comment by Robert Miles on March 18, 2011 at 1:20am

Some news on a clinical trial for type 1:

http://www.faustmanlab.org/

Not ready for volunteers yet - still looking for money to pay for phase II.

I've seen a Google Group that lists several claimed cures for type 1. None appear to be tested enough yet to tell which if any are cures for type 1, and which are more suitable as cures for excess money in your bank account.

In case you haven't noticed yet, ClinicalTrials.gov now lists clinical trials in most of the world.

Comment by SuFu, Ph.D. on February 20, 2011 at 6:32am

Meg - go to clinicaltrials.gov, search for trials, advanced search, put diabetes in the search and then add the states you want to search in.

You have to be on a pump to try out the new pumps. As far as I know, that's the only general requirement. Each trial may have more specific requirements to reach the desired endpoint.

Comment by Meg on October 21, 2010 at 1:03pm

Anybody know if there are any trials in MA or RI going on. Everything seems to be in CA or FL, and I cannot take that much time out of work.
Also, how do you become a person that does the trials on new pumps?

Comment by Megan on September 7, 2010 at 11:22am

If you are in the San Diego are or surrounding areas..we have on going clincial trials for type one and type two diabetes..email me if you are interested..some of our trials consist of device( meter,cgm,pump,etc) or Pharmaceutical ( oral medications or insulin).

Comment by Hockey Mom on August 4, 2010 at 10:42am

Tolerex, Inc just announced at the end of June 2010 that they are enrolling an additional 400 people to a new Phase III Confirmatory Trial in addition to the 240 enrolled in the current Phase III Defend Trial. You must be recently diagnosed within 90 days because the drug helps the immune system fight off the attack on the beta cells.

Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer hypoglycemic events, fewer hyperglycemic excursions, and a reduction in long-term disease complications in established type 1 diabetes patients, as referenced in the Diabetes Control and Complications Trial (DCCT).

My son is in a similar study, Protege Phase III, using a similar drug and protocol if anyone has questions or is considering this.

Comment by Michelle on February 6, 2010 at 8:38am

I am currently in an islet cell transplant study at the University of Minnesota.

Comment by Xanthasun on July 17, 2009 at 9:48am

Emily Joy- I was looking at clinical trials and found this one that is looking for people ≤5 years since T1D was diagnosed (not me). Not sure if the rest matches up for you, but there are probably more that are looking for more recently diagnosed people.

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