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Clinical Trial Details

Trial ID: L5653
Source ID: NCT02215200
Associated Drug: Anti-Thymocyte Globulin (Atg)
Title: ATG-GCSF in New Onset Type 1 Diabetes
Acronym: ATG-GCSF
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02215200/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Anti-Thymocyte Globulin (ATG)|DRUG: Granulocyte colony stimulating factor (GCSF)|DRUG: Placebo (for ATG)|DRUG: Placebo (for GCSF)
Outcome Measures: Primary: Change in Area Under the Stimulated C-peptide Curve From Baseline to 12 Months., The C-peptide 2 hour area under the curve (AUC) mean is calculated at baseline and 12 months and measured in nmol/L. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis")., -10, 0 15, 30, 60, 90, and 120 minutes post-dose at baseline and 12 months |
Sponsor/Collaborators: Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|National Center for Research Resources (NCRR)|Juvenile Diabetes Research Foundation|American Diabetes Association|Sanofi|The Leona M. and Harry B. Helmsley Charitable Trust|Amgen
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 89
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-12
Completion Date: 2018-08
Results First Posted: 2020-03-02
Last Update Posted: 2020-03-02
Locations: University of California - San Francisco, San Francisco, California, 94158-2549, United States|Stanford University, Stanford, California, 94305, United States|Barbara Davis Center, Aurora, Colorado, 80045, United States|Yale University, New Haven, Connecticut, 06519, United States|University of Florida, Gainesville, Florida, 32610, United States|University of Miami, Miami, Florida, 33136, United States|University of South Florida Diabetes Center, Tampa, Florida, 33612, United States|Indiana University-Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Columbia University-Naomi Berrie Diabetes Center, New York, New York, 10032, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37232, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States
URL: https://clinicaltrials.gov/show/NCT02215200