Trial Not a Failure for Us

My daughter Samantha joined the Defend 2 clinical trial for the drug otelixizumab within 3 months of her T1 diagnosis. I had been reading the JDRF site & really any other diabetes info I could get my hands on, because we knew NOTHING about diabetes. When I read about some of the trials in progress, I decided Defend 2 looked like it was worth a try.

Sam joined the trial in Feb 2011. In early April, the news came out that Defend 1, the first arm of the trial, had failed to meet its goal: preserving insulin production in newly-diagnosed patients. That news was staggering for those of us in Defend 2. We had signed up with high hopes; we wanted positive results -- we wanted to be some of the first patients to see the benefits of this new treatment. But with the announcement of the Defend 1 disappointment, Defend 2 stopped enrolling & we all knew we were headed for the same heartbreak that Defend 1 patients had faced. Our trial wasn't going to make headlines. Our trial had failed, in research terminology.

The wording resonated in my head. Failure. Surely not. We said we were participating for the "greater good." Contributing to research. Yeah, we wanted the glory, the exultation, but didn't we also want to contribute to the D community? Even experiments that fumble will ultimately move us closer to the goal. We had to concentrate on that. Plus, we had been able to talk to our trial doctor frequently right after diagnosis, something that otherwise wouldn't have happened. Sam was dismissed from the hospital with a plan to see our endo in 3 months. That seemed insane to me, which is probably another reason that I started looking at trials.

Seeing our trial doctor & nurse once a week & then once a month for the past year has been immeasurably helpful. We just saw them for our last visit, as Defend 2 closes down, & it was a bittersweet meeting. No more driving 2 hours to Indianapolis for a 10-minute check-up, no more blood draws for Sam, no more working those appointments in on top of all the regular doctor appointments.

But then, we have no one to ask questions every month. Is Sam's goiter larger? What is that white patch on her arm? No reason for Sam to check her blood sugar at least 4 times a day because it's not required for the trial anymore. She even made some money by participating, but now it's over & she'll have to find a real job. No more free strips! No exchanging a broken meter for a new one with no hassle.

After a break, we'll probably look into another trial because the benefits really outweighed any drawbacks. Defend 2 wasn't a failed trial for us. I don't know how we would've made it through our first year without it.

Interesting...but in terms of the benefits, are they confined to only not having to check your blood sugar so frequently? What are the full results?

I meant Sam was required by the trial to test at least 4 times a day -- which was a good requirement for her. As a teenager, just diagnosed, she doesn't like to test much. The full results of the steady haven't been released yet, but our trial doctor told us they haven't found any significant difference between the placebo group & the drug group.