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Sponsors and Collaborators: |
University of Florida Juvenile Diabetes Research Foundation National Institutes of Health (NIH) |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00662519 |
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 |
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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 |
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 |
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Neulasta: Experimental
Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses)
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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.
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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:
Contact: Michael J Haller, MD | 352.392.2215 | hallemj@peds.ufl.edu |
Contact: Miriam Cintron | 352.273.5580 | cintrm@peds.ufl.edu |
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 |
Principal Investigator: | Michael J Haller, MD | University of Florida |
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 |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |