Type 1 Diabetes Clinical Trial
Official title:
Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes
Verified date | April 2015 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Juvenile Diabetes Research Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks. | The target population distribution of change in the Area Under the Curve in residual beta cell function (C-peptide levels) is the same for treatment and placebo. | Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks. | No |
Primary | Number of participants with adverse events | 96 Weeks | Yes | |
Secondary | Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo | 96 weeks | No | |
Secondary | Increase T regulatory cells (Treg) from the bone marrow | 12 weeks | No |
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