A Note From Dr. Faustman

I hope everyone has enjoyed the summer! As we enter the fall, we are looking forward to seeing many of you who are scheduled for blood donations at the laboratory.  We are also moving closer to participant enrollment for the Phase II clinical trial of BCG in long-term diabetics.

Several things still need to be done before we get to that point. One of the most important steps is completing ongoing research in our laboratory that will give us information about how to design the trial – specifically, how to define subgroups among long-term diabetics.

A clinical trial subgroup is a group of subjects that all have a similar characteristic.  We want to look at that characteristic—such as “less than 10 years living with diabetes”—to see if it influences how participants who have the characteristic respond to treatment compared to others.

Using this example, we might examine how “subjects living with diabetes for less than 10 years (subgroup 1) compare to “subjects with 10 or more years of diabetes” (subgroup 2).

In the upcoming Phase II clinical study, we would like to see if there are any trends among people with different durations of type 1 diabetes and different rates of C-peptide decay (the protein that is a marker of insulin secretion from the pancreas).  Therefore, in the laboratory, we are currently looking at how rates of C-peptide decay and biological variation in C-peptide secretion might differ in individual participants, as well as in subgroups of participants who had the same age of diabetes onset.  This is extremely important because it will allow us to define the overall number of study groups for the Phase II trial, in addition to the size of these various groups and the duration that we should study each subgroup.

We are also excited to be conducting follow-up studies of participants from the Phase I trial who received BCG vaccinations to identify any long-term effects.  I hope to provide you an update on that data in the coming months.

Thank you all for your continued support!

Denise L. Faustman, MD, PhD

View the full Fall 2013 Faustman Lab Newsletter