| Outcome Measures: |
Primary: Change in HbA1c, Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment, Week 0 to Week 16 | Secondary: Proportion of subjects reaching HbA1c targets, HbA1c \<7% or HbA1c ≤6.5%, Week 0 to Week 16|Change in FPG, Change from baseline in FPG after 16 weeks of treatment, Week 0 to Week 16|9-point SMPG profiles, Mean plasma glucose, Postprandial and nocturnal increments, Fluctuation of 9-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime, at 4 am and before breakfast., Week 0 to Week 16|Pre-breakfast SMPG, Mean plasma glucose, Within-subject variability of pre-breakfast SMPG., Week 0 to Week 16|Titration target, Proportion of subjects and time reaching titration targets, Week 0 to Week 16|Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication, Classification of hypoglycaemia: Level 1(glucose level below 3.9 mmol/L), Level 2(glucose level below 3.0 mmol/L) and Level 3(Severe hypoglycemia, denotes severe cognitive impairment requiring external assistance for recovery)., Week 0 to Week 16|Numbers of injection site reactions, The injection site reactions was assessed during the treatment period of 16 weeks., Week 0 to Week 16|Frequency and severity of adverse events, Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities, no or minimal medical treatment. Moderate: marked symptoms, interference with subject's daily activities，and medical treatment for alleviation without grave or permanent injury to the subject. . Severe: considerable interference with subject's daily activities， and intensive treatment and intervention needed., Week 0 to Week 16 + 14 days follow-up|Anti-drug Antibodies: Anti-INS068 Antibodies, Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported., Week 0 to Week 16+14 days follow-up|Changes in Body Weight, Change of body weight was evaluated from Week 0 to Week 16, Week 0 to Week 16|Changes in Body Mass Index, Change of Body Mass Index was evaluated from Week 0 to Week 16, Week 0 to Week 16|Change in Health Related Quality of Life Questionnaire (SF -36), Change from baseline in scores of Health-Related Quality of Life Questionnaire after 16 weeks of treatment. The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score), Week 0 to Week 16|Serum INS068 concentration, To evaluate PK of INS068, Week 0 to Week 16
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| Locations: |
National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|Clinical Trials Research, Lincoln, California, 95648, United States|Torrance Clinical Research Institute Inc, Lomita, California, 90717, United States|National Research Institute - Wilshire, Los Angeles, California, 90057, United States|ALL Medical Research, LLC, Cooper City, Florida, 33024, United States|New Generation of Medical Research, Hialeah, Florida, 33016, United States|Clinical Pharmacology of Miami, LLC, Miami, Florida, 33014-3616, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Endocrinology Associates, Inc, Columbus, Ohio, 43201, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Juno Research, LL, Houston, Texas, 77040, United States|Juno Research, LLC - Medical Center Office, Houston, Texas, 77054, United States|Juno Research, LLC - Southwest Houston Site, Houston, Texas, 77074, United States|Endeavor Clinical Trials, San Antonio, Texas, 78229, United States|Core Research Group Pty Ltd, Brisbane, Queensland, 4064, Australia|The Royal Melbourne Hospital, Melbourne, Victoria, 3050, Australia|Austin Health (Heidelberg Repatriation Hospital), Melbourne, Victoria, 3081, Australia|Peking University People's Hospital, Beijing, Beijing, 100044, China|The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400010, China|Chongqing University Three Gorges Hospital, Chongqing, Chongqing, 404100, China|Hainan General Hospital, Haikou, Hainan, 570311, China|The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050000, China|The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China|Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology, Wuhan, Hubei, 430030, China|Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210008, China|Zhongda Hospital Affiliated to Southeast University, Nanjing, Jiangsu, 210009, China|Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, 330006, China|Shengjing Hospital Of China Medical University, Shenyang, Liaoning, 110004, China|The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710004, China|Shanghai Xuhui District Central Hospital, Shanghai, Shanghai, 200031, China|Shanghai Putuo District Central Hospital, Shanghai, Shanghai, 200062, China|First Hospital of Shanxi Medical University, Taiyuan, Shanxi, 030001, China|West China Hospital,Sichuan University, Chengdu, Sichuan, 610000, China|Yibin Second People's Hospital, Yibin, Sichuan, 644000, China
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