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: April 8, 2015
Last verified: April 2015

April 16, 2008
April 8, 2015
April 2008
March 2014   (final data collection date for primary outcome measure)
  • Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks. [ Time Frame: Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks. ] [ Designated as safety issue: No ]
    The target population distribution of change in the Area Under the Curve in residual beta cell function (C-peptide levels) is the same for treatment and placebo.
  • Number of participants with adverse events [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
  • Area Under the Curve C-peptide at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00662519 on ClinicalTrials.gov Archive Site
  • Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Increase T regulatory cells (Treg) from the bone marrow [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Increase in Treg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Neulasta in Type 1 Diabetes
Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes

The primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe. The secondary purpose of this research study is to determin if giving GCSF to patients with T1D changes the immune system or preserves insulin production.

As a participant in this study the following will happen:

Blood test, Mixed meal Tolerance Test (MMT) to find out how much C-peptide is being produced, Human Leukocyte Antigen (HLA) test, Hemoglobin A1C (HbA1c) test for overall blood sugar control, and randomized to either receive the 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) or a placebo (no medication).

Interventional
Phase 1
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 (Pegylated)
    Subjects will receive 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: Pegylated granulocyte colony stimulating factor (GCSF)
  • Drug: Placebo
    Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. 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: Saline
  • Dietary Supplement: Mixed Meal Tolerance Test (MMTT)
    This is a 2 hour test to find out how much C-peptide is being produced. C-peptide is used to measure the insulin being made by the cells of the pancreas. Both groups will have this test performed.
  • Other: Blood test
    HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.
    Other Name: Hemoglobin A1C (HbA1c)
  • Other: DNA Test
    The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.
    Other Name: Human Leukocyte Antigen (HLA)
  • Experimental: Neulasta
    Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses). In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
    Interventions:
    • Drug: Neulasta (Pegylated)
    • Dietary Supplement: Mixed Meal Tolerance Test (MMTT)
    • Other: Blood test
    • Other: DNA Test
  • Placebo Comparator: Placebo
    Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
    Interventions:
    • Drug: Placebo
    • Dietary Supplement: Mixed Meal Tolerance Test (MMTT)
    • Other: Blood test
    • Other: DNA Test
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
April 2015

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