Defend or Protege Clinical Trials

Has any one else considered or participated in either of these two Clinical Trials for their newly diagnosed (within 90 days) children ? They both try to preserve and stop the attack on the beta cells. Both are in Phase III trials.

I haven’t heard of this I would like some more info. My daughter was recently diagnosed with type 1 about 2 months ago.

Me too, my son was diagnosed June 10th

My sons doctor is also a diabetes researcher so he made sure that we were aware of this newest protocol.

In type 1 diabetes, some T cells (called T effector cells) mistakenly attack and destroy the cells in the pancreas that make insulin — the beta cells. monoclonal antibodies are being studied to determine if it can reduce this attack on beta cells, preserving the beta cells’ normal ability to make insulin. Basically, as it was explained to us the “honeymoon period” is when the cells are slowly dieing over a year or so. This drug tries to stop the attack and rescue any cells that can recover and begin to make insulin again. This ability to make some of your own insulin has been show in another “lifestyle” clinical trial to be protective in avoiding some of the more severe side effects of diabetes.

Although, this is not a cure because we still have to supplement insulin and do everything else, we hope that he can stay in the honeymoon period for a long time. We went through the drug infusions last fall and are now in the “wait and see” mode. We have been to lots of followup appointments and still have a year to go where they will compare his #s during fasting glucose testing to the placebo group. We know that he got the drug because of his strong side effects to the drug. Being 15, he was 1 pound into the adult weight range and received the adult dose.

The trial websites are and There are age requirements (8 & 12 were the earlier phases) and other restrictions on the websites.

We are glad we participated and hope since Tolerex announced last month that they are opening another 400 spots in an additional confirmatory Phase III trial that this drug will go to FDA approval over the next several years and be available to every child who gets Type 1 Diabetes.

I wanted to participate but didn’t find out about it until my daughter was at 110 days. I was SO bummed.

Did you son’s insulin usage go down? How is he doing now, do you think he got the study drug? We just did the infusions of the Phase III trial.

No, we were trying for another trial and were rejected; then her honeymoon ended shortly thereafter. She was dx’d five years ago and a lot less options. You bet we would try again, if only we could. If you decide to go forward, read the literature on both trials and see which one sounds more promising. Let us know how things progress; very interested and hope you have a good outcome, if you choose to do it.

We know my son got the drug because he had a severe reaction and eventually infusions of the drug had to be stopped before the 14 day first dose. They would not consider giving him the second 14 day dose six months later as planned but continue to monitor him. They said that some of the few that have had to discontinue dosing have actually had some of the best results. We saw in the JDRF Newsletter that in the Defend Study results they felt that 7 days was the optimal dose anyway.

We have just passed the one year mark which should put us out of the honeymoon phase and he should be needing more insulin. We have not seen any large increases of insulin although it is hard to compare since we went from a nightly shot of Levemir for basal to the Omnipod Pump with Apidra infused based on an hourly amount in June. The bolus amounts depend more on the amount of carbs he eats and that depends on his activity level and his growth.

That is too bad. Our doctor talked to us about the study at the first appt. It was a bit overwhelming and we were still dealing with the shock of the diagnosis. The pamphlet sat untouched for at least a week before I even mentioned it to my husband. Once we started researching we couldn’t participate fast enough. We were the first patient to do the study for our doctor. I guess if you endo isn’t participating it isn’t on their mind.

the current study is only 8 days of infusions. I was told both teens and adults get the same dose, which was surprising. I noticed a new defend study that offered redosing at 6 months for adults only. From what I read the drug preserves the beta cell function for 2 years, then there starts to be a decrease again. I’m hoping that we got the drug and that they will redose for teens.