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Clinical Trial Details

Trial ID: L2343
Source ID: NCT03182426
Associated Drug: Plerixafor
Title: Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Plerixafor|DRUG: Alemtuzumab|DRUG: Anakinra|DRUG: Etanercept|DRUG: Liraglutide
Outcome Measures: Primary: Change of 2-hour mixed meal stimulated C-peptide AUC, This AUC will be normalized by dividing it by 120 minutes (the number of minutes over which it is determined), and will be adjusted by inclusion of baseline C-peptide AUC as a covariate in the analysis., Baseline, Month 3, 6, 9, 12, 18 and 24|Rate of Serious Adverse Event/Medical Event of Special Interest, Within 24 months | Secondary: "Responder" status, A subject is considered a responder if at the given time point, the subject has: a) HbA1c ≤6.5% and b) mean daily insulin use \< 0.5 IU/kg/day over 7 consecutive days during the 2 weeks preceding the visit., Month 3, 6, 9, 12, 18 and 24|Exogenous insulin usage, Mean total daily insulin dose assessed over 7 consecutive days during 2 weeks preceding clinic visits, Baseline, Month 3, 6, 9, 12, 18 and 24|Proportion of subjects with HbA1c ≤6.5%, Baseline, Month 3, 6, 9, 12, 18 and 24|Proportion of subjects with HbA1c ≤7.0%, Baseline, Month 3, 6, 9, 12, 18 and 24|Proportion of subjects free from severe hypoglycaemia, Proportion of subjects free from severe hypoglycemia reported frequency of hypoglycemia by Hypo Score and Lability Index and CGMS, Baseline, Month 3, 6, 9, 12, 18 and 24|Proportion of subjects progressing to complete beta cell loss, Proportion of subjects who become C-peptide negative, Baseline, Month 3, 6, 9, 12, 18 and 24|Autoantibodies associated with T1DM, Including GAD, ICA512, IA2A, ZnT8 and mIAA, Baseline, Month 24 or the study withdrawal visit|T1DM T-cell autoreactivity, Baseline, Month 3, 6, 9, 12, 18 and 24|T-cell phenotyping, Baseline, Month 3, 6, 9, 12, 18 and 24
Sponsor/Collaborators: Sponsor: University of Alberta | Collaborators: Alberta Innovates Health Solutions
Gender: ALL
Age: ADULT
Phases: PHASE1|PHASE2
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-08-15
Completion Date: 2024-07-15
Results First Posted:
Last Update Posted: 2024-07-19
Locations: University of Alberta, Edmonton, Alberta, T6G 2C8, Canada
URL: https://clinicaltrials.gov/show/NCT03182426