Status:
COMPLETED
Neulasta in Type 1 Diabetes
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-45 years
Phase:
PHASE1
Brief Summary
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 secon...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00662519
Start Date
April 1 2008
End Date
March 1 2014
Last Update
April 9 2015
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610