Expired Study
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Gainesville, Florida 32610


Purpose:

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.


Study summary:

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).


Criteria:

Inclusion Criteria: - Must be > 12 years old and have a confirmed diagnosis of "recent onset T1D" as defined by: - T1D for < 6 months, - Stimulated C-peptide ≥ 0.2 pmol/ml - Presence of at least one diabetes-related autoantibody (e.g., GAD, IA-2, IAA, ICA) - Normal screening values for CBC - Willing to comply with intensive diabetes management - No history of allergy to GCSF - Females having reproductive potential must be willing to avoid pregnancy and have a negative pregnancy test Exclusion Criteria: - Known hypersensitivity to E.Coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product - Chronic use of steroids or other immunosuppressive agents - Active infection - Inability to maintain intensive diabetes management - Pregnancy - History of malignancy - Currently participating in another type 1 diabetes treatment study. - Use of non-insulin pharmaceuticals that affect glycemic control


NCT ID:

NCT00662519


Primary Contact:

Principal Investigator
Michael J Haller, MD
University of Florida


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32610
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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