Type 1 Diabetes: Age 18 to 45 Years – Within Three Months of Diabetes Diagnosis (IMATINIB/Gleevec)
DRUG NAME: IMATINIB (Gleevec)
Study Name: Safety and Efficacy of Imatinib for Preserving Beta-cell Function in New-Onset Type 1 Diabetes
Study Sponsors: Juvenile Diabetes Research Foundation International (JDRF)
Principal Investigator: Stephen E. Gitelman, MD
Who can sign up for this study? Volunteers must be 18-45 years old and have had diabetes for no more than 100 days.
In addition, volunteers cannot have any of the following conditions:
- No heart disease
- No kidney problems
- No pregnancy or breastfeeding
What is this study about? The UCSF Diabetes Program is conducting a study to see if imatinib is a safe and effective medication to preserve β-cell function in newly diagnosed T1DM individuals.
What will happen in this study? All volunteers will undergo a screening visit where they will be asked questions about their medical history, undergo a physical exam, and provide blood and urine for tests. Volunteers who qualify and are enrolled will receive a 6-month course of imatinib or matching placebo tablet. You cannot choose which group you will be in. You will be randomly chosen to be in a group. Neither you nor the study team will know which group you are in.
All volunteers will be monitored for 2 years to assess their overall health and to perform laboratory testing to determine the effects of the treatment. This will require several visits to UCSF for laboratory testing during this period. There will be follow-up visits at 2 weeks and 1, 2, 3, 4, 5, 6, 9, 12, 18, and 24 months. Blood will be drawn at each visit for lab work.
How long will this study last? Each volunteer will be followed for approximately 2 years.
Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time and effort.
For more information please contact:
Kathleen Fraser at 415-353-9084 or firstname.lastname@example.org