Type 1 Diabetes Clinical Trial
Official title:
Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes
The primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe. The secondary purpose of this research study is to determin if giving GCSF to patients with T1D changes the immune system or preserves insulin production.
As a participant in this study the following will happen:
Blood test, Mixed meal Tolerance Test (MMT) to find out how much C-peptide is being
produced, Human Leukocyte Antigen (HLA) test, Hemoglobin A1C (HbA1c) test for overall blood
sugar control, and randomized to either receive the 12 week course of Neulasta (Pegylated
granulocyte colony stimulating factor (GCSF)) or a placebo (no medication).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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