Primary Endpoint Results

This is to inform you that the overall study results of the Imatinib (also referred to by the tradename Gleevec) in New Onset Type 1 Diabetes Study (GleeT1D) have been reported on Monday, June 12th at the annual meeting of the American Diabetes Association (ADA). As a study participant, we want to provide you with this information as soon as it is made available to the scientific community.

This study, to evaluate the effectiveness and safety of Imatinib in patients with type 1 diabetes, was conducted at 9 sites and enrolled a total of 67 participants. We had excellent study participation by all study participants. Participants experienced side effects that were expected from prior studies with this drug.

The idea for the study was that this drug would be helpful to people with type 1 diabetes because of its effect on T cells, the immune cells that are thought to attack the insulin producing beta cells in the pancreas.   In addition, more recent studies suggest that it might also lower the stress to beta cells, and help preserve them. The overall desired effect was to prevent the normal decline in insulin secretion seen in the months after diagnosis in people with type 1 diabetes.

We are pleased to report that after 12 months in the trial, individuals who received Imatinib had better beta cell function with more insulin secretion, and used lower insulin doses, than those who received the placebo tablets.

While these results are promising, this does not mean the study is over. The study is designed to observe all participants out to 24 months, to see what the effect of this therapy is over time. For those of you who have already reached this endpoint, we thank you for your commitment to the study. For those who have upcoming visits, we look forward to seeing you in the near future in the Clinical Research Center. When all subjects have completed this 24 month visit, in about 1 year from now, you will be informed of your group assignment (Imatinib versus the placebo) and we will provide information about how your insulin secretion and HbA1C changed during the course of the study.

We are sure you have many more questions about the GleeT1D study results and future visits. Please be assured that your study team will be contacting you soon after the ADA meeting to review these findings in more detail. In the meantime, thank you again for your continued participation in this important trial.

A member of your research study team will be contacting you to discuss these results with you individually after the ADA meeting.   You will be given an opportunity to ask questions and will be given information about further follow-up visits. Thank you for your continued participation in this study.