| Outcome Measures: |
Primary: Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)], Superiority of mean change in the percentage of TIR \[3.9-10.0 mmol/L (70-180 mg/dL)\] from baseline to Week 20 of iGlarLixi vs Gla-100, from baseline to Week 20 | Secondary: 2a Proportion (%) of participants achieving TIR target as >70%, Week 20|2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL), from baseline to Week 20|2c Change (mg/dL) in mean daily glucose, from baseline to Week 20|2d Proportion (%) of participants achieving composite target of TIR as >70% [3.9-10.0 mmol/L (70-180 mg/dL)] with TAR as <25% [>10.0 mmol/L (>180 mg/dL)] with TBR as <4% [<3.9 mmol/L (<70 m)/dL)], Week 20|Change (%) in coefficient of variation (CV), from baseline to Week 20|Change (%) in the percentage of time in tight range (TITR) [3.9-7.8 mmol/L (70-140 mg/dL)], from baseline to Week 20|Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50%, Week 20|Proportion (%) of participants achieving ≥5% TIR improvement, from baseline to Week 20|Proportion (%) of participants achieving ≥10% TIR improvement, from baseline to Week 20|Change (%) in TAR >13.9 mmol/L (>250 mg/dL), from baseline to Week 20|Change (%) in time below range (TBR), * \<3.9 mmol/L (\<70 mg/dL), including \<3.0 mmol/L (\<54 mg/dL) * \<3.0 mmol/L (\<54 mg/dL) * \<3.9 mmol/L (\<70 mg/dL), including \<3.0 mmol/L (\<54 mg/dL) in nocturnal (00:00 h-05:59 h) time * \<3.0 mmol/L (\<54 mg/dL) in nocturnal (00:00 h-05:59 h) time, from baseline to Week 20|Change in mean glucose standard deviation (SD), from baseline to Week 20|Change (%) in glucose management indicator (GMI), from baseline to Week 20|Proportion (%) of participants achieving CV <36%, Week 20|Proportion (%) of participants achieving CV <32%, Week 20|Change (%) in HbA1c, from baseline to Week 12 and Week 20|Proportion (%) of participants achieving HbA1c <7%, Week 12 and Week 20|Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia, documented hypoglycemia (defined as ADA Level 1, 2 or 3), Week 20|Proportion (%) of participants achieving HbA1c <7% without body weight gain, body weight gain (≥5% compared to baseline), Week 20|Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia and without body weight gain, documented hypoglycemia (defined as ADA Level 1, 2 or 3), Week 20|Change (mmol/L) in fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG), from baseline to Week 12 and Week 20|Change (nmol/L) in fasting C-peptide and post-prandial C-peptide, from baseline to Week 12 and Week 20|Change (U and U/Kg) in insulin dose, from baseline to Week 20|Change (kg) in body weight, from baseline to Week 20|Change (%) in TIR [3.9-10.0 mmol/L (70-180 mg/dL)], TAR [>10.0 mmol/L (>180 mg/dL)] and TBR [3.0 mmol/L (<54 mg/dL)] for specific time blocks (6 am-12 pm, 12 pm-6 pm, 6 pm-12 am, and 12 am-6 am), from baseline to Week 20|Change in diabetes medication treatment satisfaction scores (total score and by subscales), using the treatment-related impact measure diabetes (TRIM-D) questionnaire, from baseline to Week 20|AE, serious adverse event (SAE), and adverse event of special interest (AESI), from screening to week 21|Overall hypoglycemia events and rates, from screening to week 21|Nocturnal (00:00 h-05:59 h) hypoglycemia events and rates, from baseline to Week 20|Confirmed hypoglycemia (ADA Level 1, 2 and 3), * ADA Level 1: Measurable glucose concentration \<70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L) * ADA Level 2: Measurable glucose concentration \<54 mg/dL (3.0 mmol/L) that needs immediate action * ADA Level 3: Severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery, from baseline to Week 20
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