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| ID | Type | Description | Link |
|---|---|---|---|
| JDRF 11-2007-825 | Other Grant/Funding Number | JDRF | |
| 1R21DK078863-01A1 | U.S. NIH Grant/Contract | View source | |
| GCRC 683 | Other Grant/Funding Number | GCRC |
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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neulasta | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neulasta (Pegylated) | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks. | 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. | Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks. |
| Number of participants with adverse events | 96 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo | 96 weeks | |
| Increase T regulatory cells (Treg) from the bone marrow | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Haller, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
| C423652 | pegylated granulocyte colony-stimulating factor |
| D012965 | Sodium Chloride |
| D006403 | Hematologic Tests |
| D006441 | Hemoglobin A |
| D061809 | Human Papillomavirus DNA Tests |
| D006680 | HLA Antigens |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Placebo | Drug | 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) | Dietary Supplement | 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 | Other | HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups. |
|
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| DNA Test | Other | The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups. |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D006454 | Hemoglobins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005914 | Globins |
| D006420 | Hemeproteins |
| D025202 | Molecular Diagnostic Techniques |
| D005821 | Genetic Techniques |
| D006649 | Histocompatibility Antigens |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D007519 | Isoantigens |