| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24, A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including treatment, background therapy, and visit as fixed classification effects, baseline HbA1c and baseline estimated glomerular filtration rate (eGFR) as the linear covariates, treatment by visit interaction, and baseline HbA1c by visit interaction., At baseline (Week 0) and at Week 24 | Secondary: Percentage of Participants With HbA1c<7.0% at Week 24, Percentage of participants with glycosylated haemoglobin A1c (HbA1c) \<7.0% at Week 24 is reported., At Week 24|Change in Body Weight From Baseline to Week 24, Change in body weight from baseline to Week 24 is reported. A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline body weight, and its interaction with visit., At baseline (Week 0) and at Week 24|Change From Baseline in Systolic Blood Pressure (SBP) at Week 24, A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline SBP and its interaction with visit., At baseline (Week 0) and at Week 24|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 24, A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline DBP and its interaction with visit., At baseline (Week 0) and at Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline FPG and its interaction with visit., At baseline (Week 0) and at Week 24|Change From Baseline in 2-hour Post-prandial Glucose (PPG) at Week 24, The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates., At baseline (Week 0) and at Week 24|Number of Participants With Confirmed Hypoglycaemic Events, Confirmed hypoglycemic events refer to the hypoglycaemic events with a plasma glucose value of ≤70 milligrams per deciliter (mg/dL) or where assistance was required., From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.|Number of Participants With Adjudicated Diabetic Ketoacidosis (DKA) Events, The risk of DKA had to be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty in breathing, confusion, unusual fatigue or sleepiness. In case of a suspected DKA, the investigator was to ensure that appropriate tests were performed at the earliest opportunity according to 2017 China Type 2 diabetes mellitus (T2DM) guidelines. An independent external Clinical event committee (CEC) was established to adjudicate centrally and in a blinded fashion events suspected of DKA and certain hepatic events. DKA was investigated using both broad and narrow Boehringer Ingelheim customised MedDRA query (BIcMQs)., From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.
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| Locations: |
Peking University First Hospital, Beijing, 100034, China|Peking University People's Hospital, Beijing, 100044, China|Peking University Third Hospital, Beijing, 100191, China|Beijing Pinggu Hospital, Beijing, 101200, China|The Second Hospital of Jilin University, Changchun, 130041, China|The third xiangya hospital of Central South University, Changsha, 410013, China|The First Hospital, Chongqing Medical University, Chongqing, 400042, China|Chongqing Three Gorges Central Hospital, Chongqing, 404000, China|Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510150, China|The Second Affiliated Hospital of Nanjing Medical University, Hangzhou, 210011, China|The Affiliated Hospital of Hangzhou Normal University, Hangzhou, 310015, China|Anhui Provincial Hospital, Hefei, 230001, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, 471000, China|Jiangxi Provincial People's Hospital, Nanchang, 330006, China|The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China|The Second Affiliated Hospital to Nanchang University, Nanchang, 330006, China|The affiliated hospital of medicalcollege qingdao university, Qingdao, 266005, China|Tongren hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200051, China|Centre Hospital of Putuo District, Shanghai, Shanghai, 200062, China|Shanghai Fifth People's Hospital affiliated to Fudan University, Shanghai, 200240, China|Shengjing Hospital of China Medical University, Shenyang, 110072, China|Suzhou Municipal Hospital, Suzhou, 215002, China|The First Affiliated Hospital of Soochow University, Suzhou, 215006, China|Tianjin Medical University Chu Hisen-I Memorial Hospital, Tianjin, 300070, China
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