| Outcome Measures: |
Primary: Change in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 48 weeks between IMCY-0098 and placebo groups, The area under the stimulated C-peptide response curve over the first two hours of a MMTT, From baseline to 48 weeks | Secondary: Changes in stimulated C-peptide response during the first two hours of a MMTT for the two doses of IMCY-0098 versus placebo, The area under the stimulated C-peptide response curve over the first two hours of a MMTT, From baseline to 24 months|Difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups, DBS C-peptide measurements, From baseline to 48 weeks|Changes in DBS C-peptide measurements at each visit comparing each dose with placebo, The DBS C-peptide responses at each visit, From baseline to 24 months|Effects of each dose of IMCY-0098 on HbA1c, Change in HbA1c, From baseline to 24 months|Effects of each dose of IMCY-0098 on hypoglycaemic events, Number of treatment-emergent severe hypoglycaemic episodes, From baseline to 24 months|Effects of each dose of IMCY-0098 on diabetic ketoacidosis (DKA) episodes, Number of treatment-emergent episodes of DKA, From baseline to 24 months|Effects of each dose of IMCY-0098 on daily total insulin dose, Change in insulin requirements as the daily total dose (three days average) in units per kg body weight, From baseline to 24 months|Effects of each dose of IMCY-0098 on Continuous Glucose Monitoring (CGM) measures, CGM time in range (70-180 mg/dL, 3.9- 10.0 mmol/L), time above range (\>180 mg/dL, \>10.0 mmol/L), time below range (\<70 mg/dL, \< 3.9 mmol/L) during 10 days compared to the reference period (first 10 days after randomization), From baseline to 24 months|Impact of IMCY-0098 at each dose on autoantibodies against GAD65, IA 2, ZnT8 and insulin over time, Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A), From baseline to 24 months|To evaluate the safety features of IMCY-0098 during treatment period, Occurrence, intensity and relationship of any listed injection site and systemic AEs during a 7-day follow-up period after each dose, Up to 7 days after the last dose|To evaluate the safety features of IMCY-0098 during the whole study duration, Occurrence, intensity and relationship of any unlisted injection site and AEs and occurrence and relationship of all SAEs and abnormality in physical examination, vital signs, 12-lead ECG, Up to 48 weeks|To evaluate the safety features of IMCY-0098 on lymphocytes ratio, Measure of CD4+/CD8+ lymphocytes ratio, Up to 48 weeks
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| Locations: |
University of Alabama at Birmingham, Birmingham, Alabama, 35205, United States|Barbara Davis Center, Aurora, Colorado, 80045, United States|University of Chicago, Chicago, Illinois, 60637, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Princess Alexandra Hospital, Brisbane, Australia|Royal Melbourne Hospital, Melbourne, Australia|St. Vincent's Hospital, Melbourne, Australia|Royal North Shore Hospital, Sydney, Australia|Université Libre de Bruxelles - Hôpital Erasme - ULB, Brussels, Belgium|UZ Brussels, Brussels, Belgium|Katholieke Universiteit Leuven UZ Gasthuisberg, Leuven, Belgium|Ospedale San Raffaele S.r.l., Milan, Italy|AOU Pisana - Ospedale Cisanello, Pisa, Italy|Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas, Lithuania|Klaipeda university hospital, Klaipeda, Lithuania|Vilnius university hospital Santaros klinikos, Vilnius, Lithuania|UMC - University Children's Hospital, Ljubljana, Slovenia|Department of clinical sciences, CRC/Malmö, Lund University, Lund, Sweden|Addenbrooke's Hospital, Cambridge, United Kingdom|University Hospital of Wales, Cardiff, United Kingdom|Royal Infirmary of Edinburgh, Edinburgh, United Kingdom|Royal Devon and Exeter Hospital, Exeter, United Kingdom|St James´s University Hospital, Leeds, United Kingdom|Leicester General Hospital, Leicester, United Kingdom|Guy's and St Thomas' Hospital, London, United Kingdom|Royal London Hospital, London, United Kingdom|St George's Hospital, London, United Kingdom|Royal Victoria Infirmary, Newcastle, United Kingdom|Churchill Hospital, Oxford, United Kingdom
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