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Neulasta in Type 1 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00662519
First received: April 16, 2008
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 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 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 25, 2013
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 May 23, 2013