Neulasta in Type 1 Diabetes

This study is currently recruiting participants.

Verified by University of Florida, February 2009

First Received: April 16, 2008 Last Updated: February 20, 2009 History of Changes

Sponsors and Collaborators:	University of Florida Juvenile Diabetes Research Foundation National Institutes of Health (NIH)
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00662519

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Pegfilgrastim

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 ]

Estimated Enrollment:	21
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Neulasta: Experimental 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.
Placebo: Placebo Comparator	Drug: Placebo Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662519

Contacts

Contact: Michael J Haller, MD	352.392.2215	hallemj@peds.ufl.edu
Contact: Miriam Cintron	352.273.5580	cintrm@peds.ufl.edu

Locations

United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Contact: Michael J Haller, MD 352-392-2215 hallemj@peds.ufl.edu
Principal Investigator: Michael J Haller, MD

Sponsors and Collaborators

University of Florida

Juvenile Diabetes Research Foundation

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Michael J Haller, MD

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida ( Michael Haller, MD / Assistant Professor )
Study ID Numbers:	UF IRB 280-2006, JDRF 11-2007-825, NIH 1R21DK078863-01A1, GCRC 683
Study First Received:	April 16, 2008
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00662519 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009