iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

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).

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).

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.

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.

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.

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).

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).

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.

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 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.

Routine HbA1c value was used to determine the requirement of rescue medication. Threshold value was HbA1c >8% at Week 12 or later on despite appropriate corrective actions. Percentages are rounded off to the tenth decimal place.

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).

During the study, participants were instructed to document the presence of hypoglycemic episodes in their study diary. Number of participants who met ADA definition of hypoglycemia during the treatment period are reported.

• 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.

The on-treatment period (ie, treatment-emergent [TE] period) was defined as the period from the first injection study treatment to the last injection of study treatment + 3 days (1 day for hypoglycemia).

During the study, participants were instructed to document the presence of hypoglycemic episodes in their study diary. Percentage of hypoglycemic events per participant-year during on-treatment period are reported. The on-treatment period (TE period) was defined as the period from the first injection study treatment to the last injection of study treatment + 3 days (1 day for hypoglycemia).

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any adverse event that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a suspected transmission of any infectious agent via an authorized medicinal product. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. TE period was defined as the period from the first injection study treatment to the last injection of study treatment + 3 days.

Vital signs assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) in sitting position with their arm outstretched in line with mid-sternum and supported and weight. Criteria for PCSA: SBP: <=95 millimeters of mercury (mmHg) and decrease from baseline >=20 mmHg, >=160 mmHg and increase from baseline >=20 mmHg; DBP :<=45 mmHg and decrease from baseline >=10 mmHg,>=110 mmHg and increase from baseline >=10 mmHg; HR: <=50 beats/min and decrease from baseline >=20 beats/min,>=120 beats/min and increase from baseline >=20 beats/min; Weight >=5% decrease from baseline, >=5% increase from baseline.

Criteria for PCSA: For Hemoglobin (Hb), there are 3 criteria: (1)<=115 grams (g)/L (Male[M]) or <=95 g/L (Female[F]), (2)>= 185 g/L (M) or >=165 g/L (F), and (3) decrease from baseline >=20 g/L; Hematocrit: <=0.37 volume/volume (v/v) (M) or <=0.32 v/v (F), >=0.55 v/v (M) or >=0.5 v/v (F); Red blood cells (RBC): >=6 Tera/L; Platelets: <100 Giga/L, >=700 Giga/L; White blood cells (WBC): <3.0 Giga/L (Non-Black [NB]); <2.0 Giga/L (Black [B]) or >=16.0 Giga/L; Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); Lymphocytes: >4.0 Giga/L; Monocytes: >0.7 Giga/L; Basophils: >0.1 Giga/L; Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L).

Criteria for PCSA: Lipase: >=3 ULN; Amylase: >=3 ULN; Sodium: <=129 mmol/L; >=160 mmol/L; Potassium: <3 mmol/L, >=5.5 mmol/L; Creatinine: >=150 micromoles per liter (umol/L), >=30% or >=100% change from baseline; Glomerular filtration rate (GFR): >=60-<90 mL/minute(min)/1.73 square meter (m^2) (mild decrease in GFR), >=30-<60 mL/min/1.73m^2 (moderate decrease in GFR), >=15-<30 mL/min/1.73m^2 (severe decrease in GFR),<15 mL/min/1.73m^2 (end stage renal disease); Creatinine clearance (CG): >=60-<90 mL/min (mild decrease in GFR), >=30-<60 mL/min (moderate decrease in GFR), >=15-<30 mL/min (severe decrease in GFR), <15 mL/min (end stage renal disease); Urea nitrogen (BUN): >=17 mmol/L and Uric acid: <120 or >408 umol/L; Alanine transaminase (ALT) and aspartate transaminase (AST): >3/5/10/20 ULN. Alkaline phosphatase:>1.5 ULN, total bilirubin (TBILI): >1.5 or >2 ULN, ALT and TBILI:> ALT>3ULN and TBILI >2 ULN and Conjugated and total bilirubin: >35% TBILI and TBILI >1.5 ULN.