Type 1 Diabetes Clinical Trial

From a diabetes educator’s perspective it is interesting to note that despite your son being recently diagnosed with T1DM, his daily insulin requirements have been reduced, at times, to only 3 units of a rapid acting insulin? Would this represent a large reduction from his previous daily requirements?

It is also interesting to see that he only experienced transient headaches during the (8 day) dosing period for the Defend-2 trial. I am hoping that they were treatable and allowed him to enjoy the normal daily activities of a 12 year old.

It will be interesting to see if the recent reduction in blood glucose levels fluctuations that you described is a phenomenon that is enduring.

In reading the phase 2 trials and talking to physicians who are PI on DEFEND-1, DEFEND-2 or TEDD a significant reduction in insulin usage is not at all an uncommon thing. In fact, in younger people who get on otelixizumab (TRX4) it is not uncommon for them to be able to completely discontinue usage of all insulin. I know of two patients on TEDD who are still off insulin one year after completion of dosing. I have had stable acute insulin usage for >7 months post dosing with basal levels fluctuating directly with units/kg bw.

While the evaluation of daily insulin requirements is common in clinical practice, a number of patient oriented self-management variables can affect insulin usage.

The focus of some type 1 diabetes trials has been the preservation of beta cell function.

While daily insulin usage may be considered a reflection of beta cell function, it seems intutitively that evaluating c-peptide levels may be a more reliable measure of beta cell function in such patients.