Diamyd : Prevention vs Intervention, why should we care?

Long time since last entry and some news regarding the Diamyd GAD65 trials to prevent or improve Type 1 Diabetes.

Today we got news that the prevention trial mentioned before has started and three children have been treated. Why is this important and what differs this trial (prevention) from the other trials (Phase III Intervention)?

We have very good ways of screening children for Type 1 Diabetes. With that information Diamyd is trying to see if early injections with GAD65 will not only preserve beta cells but actually stop the disease before outbreak. Prevention trials take 5+ years to give good enough data, but just because it takes a long time doesn't mean it's not worth doing. Phase III Intervention trials are running in parallel, both in Europe and in America (actually three separate trials are done in America).

We have also news that the American part of the Phase III trial is reducing the minimum age to 10 years (from 16 years). This will reduce the time it takes to enroll patients.

Looking at older plans, Diamyd was planning to have enrolled all 640 patients in the two Phase III trials. As usual delays are a part of this kind of research and now we are looking at end of 2009 for the last patient to be enrolled (delay of 6 months).

Overall it looks good! Safety is the key here, and a safe drug that works a little is 10 times better than a dangerous drug that works good (well not always, but while treating children!!). So we are still waiting for Phase III data, planned Q1 2011, fingers crossed.

Have a nice summer!