iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis

Time frame · Baseline, Week 24

Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).

Change in HbA1c From Baseline to Week 24: Superiority Analysis

Time frame · Baseline, Week 24

Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).

Change in Body Weight From Baseline to Week 24

Time frame · Baseline, Week 24

Body weight was obtained with the participant wearing undergarments or very light clothing and no shoes, and with an empty bladder. The same scale was used throughout the study. Baseline was defined as the last available pre-dose assessment (on or before Day 1).

Percentage of Participants Reaching HbA1c <7% at Week 24

Time frame · Week 24

Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c value were considered as non-responders. Percentages are rounded off to the tenth decimal place.

Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24

Time frame · Week 24

Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c or body weight value were considered as non-responders. Percentages are rounded off to the tenth decimal place.

Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 and no Hypoglycemia During 24-Week Treatment Period

Time frame · Baseline up to Week 24

Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c or body weight value were considered as non-responders. During the study, participants were instructed to document the presence of hypoglycemic episodes in their study diary. Hypoglycemia was characterized as per American Diabetes Association (ADA) 2021 recommendations. * ADA Level 1 hypoglycemia: A measurable glucose concentration \<70 milligram/deciliter (mg/dL) (3.9 millimoles/liter \[mmol/L\]) but \>=54 mg/dL (3.0 mmol/L). * ADA Level 2 hypoglycemia: Blood glucose concentration \<54 mg/dL \[3.0 mmol/L\]; the threshold at which neuroglycopenic symptoms begin to occur and requires immediate action to resolve the hypoglycemic event. * ADA Level 3 hypoglycemia: A severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery. Percentages are rounded off to the tenth decimal place.

Change in Fasting Plasma Glucose From Baseline to Week 24

Time frame · Baseline, Week 24

Blood samples were collected at fasting state (no food or drinks \[except water\] for at least 8 hours) at indicated timepoints. Baseline was defined as the last available pre-dose assessment (on or before Day 1).

Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 24

Time frame · Baseline, Week 24

Participants were provided with a glucometer, corresponding supplies, a leaflet, and with diaries in order to perform self-measurement of plasma glucose and its recording and were trained on how to use the glucometer. The 7-point SMPG profile was measured at the following 7-points: pre-prandial (before starting a meal) and 2 hours postprandial each for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. The participants performed 7-point SMPG profile measurement over a single 24-hour period on 2 different days in the week. Baseline was defined as the last available pre-dose assessment (on or before Day 1).

Percentage of Participants Reaching HbA1c <7% at Week 24 With no Hypoglycemia During 24-Week Treatment Period

Time frame · Baseline up to Week 24

Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c value were considered as non-responders. Hypoglycemia was characterized as per ADA 2021 recommendations. * ADA Level 1 hypoglycemia: A measurable glucose concentration \<70 mg/dL (3.9 mmol/L) but \>=54 mg/dL (3.0 mmol/L). * ADA Level 2 hypoglycemia: Blood glucose concentration \<54mg/dL \[3.0 mmol/L\]; the threshold at which neuroglycopenic symptoms begin to occur and requires immediate action to resolve the hypoglycemic event. * ADA Level 3 hypoglycemia: A severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery. Percentages are rounded off to the tenth decimal place.

Percentage of Participants Reaching HbA1c <7% at Week 24 With no Clinically Relevant Hypoglycemia During 24-Week Treatment Period

Time frame · Baseline up to Week 24

Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c value were considered as non-responders. Participants who reached the specified target of HbA1c without any clinically significant symptoms of hypoglycemia as defined in ADA Levels 2 or 3 are reported. Percentages are rounded off to the tenth decimal place.

Total Daily Insulin Dose at Week 24

Time frame · Week 24

Total daily insulin dose was defined as the sum of the insulin dose from study treatment and non-study treatment (e.g., rescue therapy). It was the average of the last 3 available insulin doses recorded in the electronic case report form in the week before visit.