Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2008-04-30
2014-03-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
Blood test
HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.
DNA Test
The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.
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.
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.
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.
Blood test
HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.
DNA Test
The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.
Interventions
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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.
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.
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.
Blood test
HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.
DNA Test
The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
45 Years
ALL
Yes
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Michael J Haller, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Other Identifiers
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JDRF 11-2007-825
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GCRC 683
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UF IRB 280-2006
Identifier Type: -
Identifier Source: org_study_id
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