Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]

Time frame · Baseline (Days -14 to -1) and Week 16

The percentage of time spent in the glycemic target range of 70 to 180 mg/dL was calculated as 100 times the number of recorded measurements in the glycemic target range (70 to 180 mg/dL inclusive), divided by the total number of recorded measurements. Baseline is defined as the first 14 evaluable days of evaluable continuous glucose monitoring (CGM) data prior to first day of treatment. CGM compliance is defined as 1) at least 8 out of 14 days (not necessarily consecutive) have 100% of evaluable CGM data per 24-hour period (at least 8 days with 96 records minimum per day) OR 2) at least 9 out of 14 days (not necessarily consecutive) have ≥89% of evaluable CGM data per 24-hour period (at least 9 days with 85 records minimum per day) OR 3) at least 10 out of 14 days (not necessarily consecutive) have at least ≥80% of evaluable CGM data per 24 hour period (at least 10 days with 77 records minimum per day).

Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV)

Time frame · Baseline (Days -14 to -1) and Week 16

Glucose total CV was calculated by following: standard deviation glucose/mean glucose over 14 days x 100, and the percent change was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Change From Baseline to Week 16 in Mean Daily Blood Glucose

Time frame · Baseline (Days -14 to -1) and Week 16

A global average was computed to determine the average of the mean daily blood glucose for the 14 days at baseline and Week 16. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal

Time frame · Baseline (Days -14 to -1) and Week 16

The analysis was focused on the 4-hour interval at both baseline and Week 16 from t=0 (the timepoint at which glucose measurement was taken immediately preceding liquid meal administration) throughout the subsequent 4 hours. For each participant, the overall maximum glucose value within the described 4-hour period was determined, and the difference between the maximum glucose value at baseline and Week 16 was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Change From Baseline to Week 16 in Time Above Range (>180 mg/dL)

Time frame · Baseline (Days -14 to -1) and Week 16

The time spent above the glycemic target range was calculated as 100 times the total number of 15-minute increments of CGM data where a participant's blood glucose falls above normal range (\>180 mg/dL) at baseline, divided by the total number of 15-minute increments read (i.e., up to 1344 15-minute increments) at Week 16. This was calculated for baseline and Week 16 and the change was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Percentage of Participants Who Achieved Coefficient of Variation <36%

Time frame · Week 16

Percentage of participants achieving CV \<36% was calculated as sum of the number of participants with CV \<36% divided by the total number of participants. The endpoint was calculated using all CGM glucose readings available throughout each day for 2 weeks (Week 14-16).

Change From Baseline to Week 16 in Time in Range Per Time Blocks

Time frame · Baseline (Days -14 to -1) and Week 16

Time spent in the glycemic target range (70 to 180 mg/dL) was calculated as 100 times the number of recorded measurements in the glycemic target range (70 to 180 mg/dL inclusive), divided by the total number of recorded measurements per time block and comparing the corresponding time blocks from Week 16 to baseline. The time blocks are 12 am to 6 am, 6 am to 12 pm, 12 pm to 6 pm, 6 pm to 12 am, and 6 am to 12 am. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9%

Time frame · Week 16

The GMI was calculated as 3.31 + 0.02392 x (mean glucose in mg/dL from CGM data). The GMI was calculated by determining the number of participants who achieved \<7% and \<9% at Week 16.

Change From Baseline to Week 16 in the 4-Hour Postprandial Glucose Area Under the Concentration Time Curve From 0 to 4 Hours

Time frame · Baseline (Days -14 to -1) and Week 16

Blood samples were collected to measure the glucose values up to 4-hour after the breakfast meal. The analysis was based on a liquid meal at both baseline and Week 16 (a liquid meal administered in a fasted state and blood glucose is measured at specific time points up to 4 hours). Baseline is defined as the time period prior to administration of study drug.

Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration

Time frame · Baseline (Days -14 to -1) and Week 16

Blood samples were collected at specific intervals over a 4 hour period to measure blood glucose values following ingestion of a liquid meal and the process is repeated after 16 weeks of study drug administration following another liquid meal administration and blood glucose values measured at specific time points over 4 hours. The difference in the time to reach the maximal blood glucose value was then calculated between these two timepoints.

Percentage of Participants Who Spent <15 Minutes/Day at a Glucose Level <54 mg/dL

Time frame · Week 16

Blood glucose level was determined based upon CGM data. Percentage of participants with glucose level \<54 mg/dL for less than 15 minutes per day are reported.