Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Neulasta in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00662519
First received: April 16, 2008
Last updated: March 28, 2014
Last verified: March 2014

April 16, 2008
March 28, 2014
April 2008
March 2014   (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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 1 Diabetes
  • Drug: Neulasta (Pegfilgrastim)
    6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.
    Other Name: Pegfilgrastim
  • Drug: Placebo
    Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner
  • Experimental: Neulasta
    Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses)
    Intervention: Drug: Neulasta (Pegfilgrastim)
  • Placebo Comparator: Placebo
    Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
12 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662519
UF IRB 280-2006, JDRF 11-2007-825, 1R21DK078863-01A1, GCRC 683
Yes
University of Florida
University of Florida
  • Juvenile Diabetes Research Foundation
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Michael J Haller, MD University of Florida
University of Florida
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP