Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

Change in HbA1c From Baseline to Week 30

Time frame · Baseline, Week 30

Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine. Change in HbA1c was calculated by subtracting baseline value from Week 30 value.

Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30

Time frame · Week 30

Participants without Week 30 value for HbA1c were counted as non-responders.

Change in Plasma Glucose Excursion From Baseline to Week 30

Time frame · Baseline, Week 30

Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF).

Change in Body Weight From Baseline to Week 30

Time frame · Baseline, Week 30

Change in body weight was calculated by subtracting baseline value from Week 30 value.

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30

Time frame · Baseline, Week 30

Change in FPG was calculated by subtracting baseline value from Week 30 value.

Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30

Time frame · Baseline, Week 30

Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.

Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30

Time frame · Week 30

Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

Time frame · Baseline up to Week 30

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).

Average Daily Insulin Glargine Dose at Week 30

Time frame · Week 30

The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy.

Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30

Time frame · Baseline, Week 30

The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF.

Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

Time frame · Baseline up to Week 30

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication.