Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

Change From Baseline in HbA1c to Week 12

Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM.

Time frame: Baseline, Week 12

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24

Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period.

Time frame: Baseline, Week 12 and Week 24

Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24

Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period.

Time frame: Baseline, Week 12 and Week 24

Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point

8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.

Time frame: Baseline, Week 12 and Week 24

Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point

4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime.

Time frame: Baseline, Week 12 and Week 24

Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24

The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM.

Time frame: Baseline, Week 12 and Week 24

Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24

Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit.

Time frame: Baseline, Week 12 and Week 24

Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24

Adjusted LS means were obtained from MMRM.

Time frame: Baseline, Week 12 and Week 24

Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24

Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis.

Time frame: Week 12, and Week 24

Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =\<3.9 mmol/L (=\<70 mg/dL).

Time frame: Week 12, and Week 24

Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period

Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis.

Time frame: Baseline to Week 24

Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period

Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG \>200 mg/dL (11 mmol/L), or HbA1c \>8.5%.

Time frame: Baseline to Week 24

Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24

Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis.

Time frame: Baseline, Week 12 and Week 24

Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\<70 mg/dL (=\<3.9 mmol/L), or \< 54 mg/dL (\<3.0 mmol/L). Assessment was done by treatment period (for =\<12 weeks, for \>12 weeks to =\<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported.

Time frame: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =\<70 mg/dL (=\<3.9 mmol/L), or \< 54 mg/dL (\<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =\<12 weeks, for \>12 weeks to =\<24 weeks).

Time frame: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\<70 mg/dL (=\<3.9 mmol/L), or \< 54 mg/dL (\<3.0 mmol/L).

Time frame: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\<70 mg/dL (=\<3.9 mmol/L), or \< 54 mg/dL (\<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time).

Time frame: Day 1-Week 12, Week 13-Week 24, and 24 Week Period