| Outcome Measures: |
Primary: Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration, Mixed meal tolerance test MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC), From Baseline to Week 26 | Secondary: Change from baseline to Week 52 in mean 2-hour MMTT stimulated Cpeptide concentration, MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC), From Baseline to Week 52|Participant remaining C-peptide positive at Week 26 and Week 52, Incidence (yes/no) outcome Defined as mean 2-hour MMTT stimulated C-peptide concentration ≥0.2 nmol/L, Week 26 and Week 52|Time in range (TIR) (70-180 mg/dL) at Week 26 and Week 52, Assessed by Continuous glucose monitoring (CGM). A CGM system is a device that records interstitial glucose levels continuously throughout the day and night via a subcutaneous sensor., Week 26 and Week 52|Change from baseline to Week 26 and Week 52 in insulin dose, Expressed in IU/kg/day, From Baseline to Week 26 and Week 52|Change from baseline to Week 26 and Week 52 in glycated hemoglobin A1c (HbA1c) level, From Baseline to Week 26 and Week 52|Participant having HbA1c ≤6.5% and ≤0.25 IU/kg/day of exogenous insulin required at Week 26 and Week 52, Incidence (yes/no) outcome, Week 26 and Week 52|Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation, Up to End of Study (approx. 83 Weeks)|Incidence (yes/no) of hypoglycemic events (level 2 or 3 according to American Diabetes Association), Incidence (yes/no) outcome, Up to End of Study (approx. 83 Weeks)|Incidence (yes/no) of hyperglycemic episodes (level 2 according to American Diabetes Association), Incidence (yes/no) outcome, Up to End of Study (approx. 83 Weeks)|Incidence (yes/no) of diabetic ketoacidosis (DKA) events, Incidence (yes/no) outcome, Up to End of Study (approx. 83 Weeks)|Incidence (yes/no) of clinically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation, Incidence (yes/no) outcome, Up to End of Study (approx. 83 Weeks)|SAR442970 serum concentrations over time, Up to End of Study (approx. 83 Weeks)|Incidence of anti-drug antibodies (ADAs) over time, Up to End of Study (approx. 83 Weeks)|Change from baseline to Week 26 and Week 52 in Problem Areas in Diabetes (PAID) total score (all participants), The Problem Areas in Diabetes (PAID) is a diabetes specific instrument measuring diabetes distress. There is an adult version (18+) and a pediatric version for children 8-17 years of age. The PAID contains 20 items that describe negative emotions related to diabetes (eg, depression, anger, frustration). Item scores are summed to generate a total score. Scores range from 0 to 100, where higher total scores correspond to higher emotional distress due to diabetes, From Baseline to Week 26 and Week 52|Change from baseline to Week 26 and Week 52 in PAID immediate and theoretical domain scores (caregivers of all participants 12 to 17 y.o.), Caregiver version of PAID for parents with children 8-18 years of age consists of 18 items that measure caregiver burden. Two scores are calculated: Immediate Burden and Theoretical Burden. Scores range from 0 to 100, where higher scores correspond to greater caregiver burden., From Baseline to Week 26 and Week 52
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| Locations: |
Investigational Site Number : 1240006, Surrey, British Columbia, V3T 2V6, Canada|Investigational Site Number : 1240001, Vancouver, British Columbia, V5Y 3W2, Canada|Investigational Site Number : 1520001, Santiago, Reg Metropolitana De Santiago, 7500505, Chile
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