I was wondering if anyone else has participated in the Defend2 drug trials from Tolerx?
If your not familiar with the trial here is some info from their site:
DEFEND-2 is a phase 3 clinical study evaluating the use of otelixizumab in people with newly diagnosed type 1 diabetes. Otelixizumab is an investigational agent, which means it has not been approved by the FDA for
marketing. The goal of DEFEND-2 is to find out whether otelixizumab can help people with type 1 diabetes
by preserving their ability to make their own insulin.
~From http://www.defendagainstdiabetes.com
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Early last week I traveled to the study site (Vanderbilt, Nashville TN) for the screening tests. So far I’ve passed and it looks like I’m in. Which means I still have some natural insulin function (YAY!) and I do not have any damage to my other systems. I’m traveling to Nashville early tomorrow to stay for the week and receive the infusions.
According to the informed consent, I have a 2 in 3 chance of receiving the drug and if I do the side effects are headaches and flu like symptoms.
So has anyone else been thru this trial and any other trial? Any tips on what to expect?
Do you know if they are accepting LADAs or antibody positive type 2s? I looked at the recruiting (http://www.clinicaltrials.gov/ct2/show/NCT01123083) and they have recently changed the criteria. Before, I believe they required type 1 diagnosis accord to ADA/WHO criteria, however I don’t believe that criteria exists and they changed it. So it may well be that the trial is open to a broader set of patients than before.
In fact, I actually think it is a fundamental flaw to run trials like this without including slow onset type 1s. It is probably the slow onset type 1s who will respond best.
From my understanding of the requirements, you need to be newly diagnosed (3 months or less), be antibody positive and still have natural insulin function. Plus all the other things like no other major disorder, drug free and not yet had a flu shot.
The study nurse told me I was LADA. But I’m not real sure about that. I never had blood sugar problems, then landed in the hospital and went home on insulin. That all happened back in October (2010). My endo recommended I investigate drug trials from the first conversation I had with him while in the hospital. He has had 2 patients participate in this trial before and said it was very promising.
I would think as long as someone has the antibodies, is still making some insulin and passes the health evaluation, then they would be accepted.
I had my infusions were from Dec 10-17. It has been an interesting experience! Since I had the infusions I have needed less insulin. However I did not get the horrible headaches I had been warned of that is typical when you get the drug, so I think there is some doubt on if I actually got the drug. At this point, I'm just happy not to have to use as much insulin. :)
I was told during my stay at Vanderbilt that the study had closed to new adult recruits, then they told me they had stopped recruiting altogether. So if you are interested you might want to call and make sure they are still accepting children.
If you have any questions about my experience, don't hesitate to ask!
Great, thanks! The hospital in Indy is still taking teenagers & has sent me the info. Samantha is going on Jan 17 for the screening. I know it’s a 2/3 chance that she’ll get the drug, but it seems worth a try. They said it may cause headaches, but they’re giving Motrin & Zyrtec to combat that side effect. Maybe that worked for you if you got the drug. We’re hoping we can drive back & forth from Louisville to Indy for the 8 days if she gets in, so it will be a crazy time. Sam doesn’t want to miss that much school. Hope everything works out for you.
Hi samsmom, my 12 year old son is doing the study. He got the infusions Dec 10-18. He was diagnosed on 10/27/2010. He did well with it, of course not sure if we got drug or placebo. He did a picc line so he didn’t have to get shots everyday. His numbers do seem to be better now, so we are optimistic. I feel fortunate that he was able to participate. Good luck!
I hope she gets in! I did have a few headaches but nothing like the other two participates did. The major thing that happened to me is my blood sugar would drop 50+ points during the infusion. The study people at Vanderbilt said that is the first time they have seen that happen during the infusion time. They had seen drops after the infusion but never during. Also one of the other participates stopped having to bolus for breakfast.
Just a note of caution. The infusions made me feel like crap. I was tired and cold all the time. Even for about 4 days after. They also told me that (if the person gets the drug) it does take a toll on the immune system, so she’ll have to be careful about who she is around and hand washing. Mine was a week before Christmas and I was worried about shopping, they offered me one of those surgical masks! I declined and just shopped during low traffic times and kept antibacterial wipes with me.
My time at the clinic was about 4 hours. Prep time was about an hour, the infusion was 35 mins and then the 2 hour observation during which they keep a check on body temp and blood pressure.
I had a follow up yesterday. They had to lower my basil rate again and I have also lost a few pounds, about 5 since December. That to me was shocking! I am overweight, so any weight loss I will take. I also have thyroid problems. I asked the nurse if I did get the drug is it possible that it help my thyroid too? She said maybe, then asked that I follow up with my Endo to get my levels checked. She later told me that last year they had a few people say that after their infusions their psoriasis (also autoimmune) got better. I guess we will not know for sure until they unblind the study.
Good luck to you both!
I didn’t do Defend 2 but I did a trial with the same drug early last summer, in an unblinded and guaranteed drug phase of the study. I had one day of fairly mild headaches during the 5 day infusion set, the teen that did it the week before me was placed on vicodin day 2 due to headaches. So far everything has been fine post infusion. Diagnosed over a year ago now and still only take 6 units basal with a I:C ratio in the 1:25 range for average. I would recommend it given the potential benefits.
Sounds like Defend 2 is easier for only 4 hour observation time, I was there 8-10 hours a day just sitting there since it required resting vitals every 30 minutes or so.
Hi LizBa, my son was doing the infusions at the same time as you in Raleigh NC. We have seen a small decrease in insulin. He was taking 10-20 units of humulog before the infusions and now takes 7-12 units (with as little as 3 in an entire day a couple of times). Overall his blood sugar is much lower all of the time. Still 50/50 on if we got the drug, because it was pretty easy for him. Mild headache a couple of days. I will say his BS was ALL over the place the week after the drug, real highs and lows before it stablized. The only thing during the infusions that really made us think he may have gotten it was that he was SO TIRED on the first 2 days… Anyway, would love to know how you are doing now and how much less insulin you are taking since the study. Thansk!
Good to hear you only had mild headaches and you definitely got the drug. I thought it was interesting that teens and adults got the exact same amount of the drug. My son was only 105 pounds when he went in. Only mild headaches occassionally. Really tired on day one and two. Great news about your low insulin requirements. Keep us posted.
