| April 16, 2008 |
| February 20, 2009 |
| April 2008 |
| April 2011 (final data collection date for primary outcome measure) |
- Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Area Under the Curve C-peptide at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00662519 on ClinicalTrials.gov Archive Site |
- HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Increase in Treg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Neulasta in Type 1 Diabetes |
| Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes |
This study seeks to determine if giving a a 12 week course of Neulasta to people with recent onset type 1 diabetes is (1) safe and (2) can preserve insulin production. |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Type 1 Diabetes |
- Drug: Neulasta (Pegfilgrastim)
- Drug: Placebo
|
| Experimental: Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses) |
| |
| |
| Recruiting |
| 21 |
| April 2012 |
| April 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Must be > 18 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
After the first 6 subjects are enrolled, and if approved by both the DSMB AND medical monitor, subjects >12 years old will be enrolled. (The study currently has 5 subjects enrolled so we hope to reduce the age for enrollment in the next 3-4 months)
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
|
| Both |
| 18 Years to 45 Years |
| Yes |
|
|
| United States |
| |
| NCT00662519 |
| Michael Haller, MD / Assistant Professor, University of Florida |
| UF IRB 280-2006, JDRF 11-2007-825, NIH 1R21DK078863-01A1, GCRC 683 |
| University of Florida |
- Juvenile Diabetes Research Foundation
- National Institutes of Health (NIH)
|
| Principal Investigator: |
Michael J Haller, MD |
University of Florida |
|
|
| University of Florida |
| February 2009 |
