Principal Investigator: Peter Gottlieb, MD
COMIRB # 10-0846
The ATG-GCSF Study
The combination therapy of Thymoglobulin and Neulasta is being tested in this clinical trial. Thymoglobulin is immunosuppressant drug that affects the cells that are thought to be involved in the development of type 1 diabetes. Neulasta is a medicine that increases the number of white blood cells. This trial is designed to investigate the effect the study drug therapy on preserving beta cell function and to determine if it will help slow the progression of type 1 diabetes.
Who can participate?
Diagnosis of Type 1 Diabetes Mellitus > than 4 months, but within 2 years
· Must be > 16 years < 45
· Serologic evidence of prior EBV infection
· C-peptide level ≥ 0.1 pmol/ml (0.3ng/mL) when measured during a mixed meal tolerance test (MMTT), conducted at least 4 months from diagnosis of diabetes following a mixed meal tolerance test (MMTT)
What will happen in this study?
You will be assessed for general health and diabetes care
If you are eligible and enroll you will be assigned to either a treatment or placebo group (2:1)
You will receive two days of infusions with Thymoglobulin through an IV
You will then receive 6 Subcutaneous Injections over a 10 week period, the first immediately following the last day of infusion
You will be required to come in for follow up visits for the duration of this 2- year study
Who should I call with questions or to schedule an appointment?
Lisa Meyers (Enrollment Coordinator): 303-724-6893 or Lisa.Meyers@ucdenver.edu
Jenna Lungaro (Study Coordinator): 303-724-6758 or Jenna.Lungaro@ucdenver.edu