| Outcome Measures: |
Primary: Change in HbA1c, Change in glycated hemoglobin (HbA1c) from baseline to Week 30, From Baseline to Week 30 | Secondary: Patients with HbA1c <7.0%, Percentage of patients reaching HbA1c \<7% at Week 30, At Week 30|Patients with HbA1c ≤ 6.5%, Percentage of patients reaching HbA1c ≤ 6.5% at Week 30, At Week 30|Change in postprandial plasma glucose (PPG), Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 30, From Baseline to Week 30|Change in self-monitored plasma glucose (SMPG) profile, Absolute change in 7-point SMPG profiles from baseline to Week 30 (each time point and average daily value), From Baseline to Week 30|Patients with HbA1c <7.0% with no body weight gain, Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 30, At Week 30|Change in body weight, Absolute change in body weight from baseline to Week 30, From Baseline to Week 30|Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia, Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 30 and no documented (plasma glucose \[PG\] ≤70 mg/dL \[3.9mmol/L\]) symptomatic hypoglycemia during the 30-week randomized treatment period, At Week 30|Patients requiring rescue therapy, Percentage of patients requiring rescue therapy during the 30-week randomized treatment period, From Baseline to Week 30|Change in fasting plasma glucose (FPG), Absolute change in FPG from baseline to Week 30, From Baseline to Week 30|Confirmed hypoglycemia, Severe hypoglycemia and episodes of hypoglycemia documented with PG ≤ 70 mg/dL (3.9mmol/L) regardless of symptoms, From Baseline to Week 30|Adverse events (AEs), Number of AEs, Serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 30, From Baseline to Week 30|Immunogenicity (antibody variables), Anti-lixisenatide antibodies (in iGlarLixi group) and anti-insulin antibodies from baseline to Week 30, From Baseline to Week 30
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| Locations: |
Investigational Site Number 1560044, Baotou, 014010, China|Investigational Site Number 1560001, Beijing, 100034, China|Investigational Site Number 1560039, Beijing, 102218, China|Investigational Site Number 1560005, Changchun, 130033, China|Investigational Site Number 1560054, Changchun, 130041, China|Investigational Site Number 1560015, Changsha, 410013, China|Investigational Site Number 1560010, Chenzhou, China|Investigational Site Number 1560030, Chongqing, 400010, China|Investigational Site Number 1560025, Fuzhou, 354200, China|Investigational Site Number 1560016, Guangzhou, 510080, China|Investigational Site Number 1560053, Guangzhou, 510080, China|Investigational Site Number 1560045, Guangzhou, 510515, China|Investigational Site Number 1560021, Hefei, 230022, China|Investigational Site Number 1560018, Hohhot, 010017, China|Investigational Site Number 1560019, Huanggang, China|Investigational Site Number 1560041, Jiaxing, China|Investigational Site Number 1560040, Jinan, 250000, China|Investigational Site Number 1560007, Jinan, 250013, China|Investigational Site Number 1560026, Jinzhou, 121000, China|Investigational Site Number 1560042, Kaifeng, 475000, China|Investigational Site Number 1560003, Kunming, 650032, China|Investigational Site Number 1560032, Lanzhou, 730000, China|Investigational Site Number 1560033, Luoyang, China|Investigational Site Number 1560028, Nanjing, 210008, China|Investigational Site Number 1560013, Nanjing, 210011, China|Investigational Site Number 1560017, Nanjing, 210029, China|Investigational Site Number 1560035, Nanjing, China|Investigational Site Number 1560038, Nanjing, China|Investigational Site Number 1560046, Nantong, 226001, China|Investigational Site Number 1560008, Pingxiang, 337055, China|Investigational Site Number 1560037, Qingdao, 266003, China|Investigational Site Number 1560031, Qinhuangdao, China|Investigational Site Number 1560011, Shanghai, 200240, China|Investigational Site Number 1560002, Shanghai, 201700, China|Investigational Site Number 1560027, Shanghai, China|Investigational Site Number 1560047, Shanghai, China|Investigational Site Number 1560012, Shenyang, 110004, China|Investigational Site Number 1560006, Tianjin, 300121, China|Investigational Site Number 1560049, Urumqi, 830000, China|Investigational Site Number 1560020, Xining, 810007, China|Investigational Site Number 1560050, Xining, 810016, China|Investigational Site Number 1560036, Xuzhou, China|Investigational Site Number 1560023, Yangzhou, 225001, China|Investigational Site Number 1560022, Zhuzhou, 412007, China|Investigational Site Number 1560052, Zigong, 643002, China
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