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
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Drug: Neulasta (Pegylated)
Drug: Placebo
Dietary Supplement: Mixed Meal Tolerance Test (MMTT)
Other: Blood test
Other: DNA Test
Phase 1

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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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). 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.
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)
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)
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.
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)

Detailed Description:

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 8, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 29, 2015