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
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Drug: Neulasta (Pegfilgrastim)
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Increase in Treg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: April 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neulasta
Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses)
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
Placebo Comparator: Placebo
Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner.
Drug: Placebo
Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662519

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Michael J Haller, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00662519     History of Changes
Other Study ID Numbers: UF IRB 280-2006, JDRF 11-2007-825, 1R21DK078863-01A1, GCRC 683
Study First Received: April 16, 2008
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014