| Outcome Measures: |
Primary: Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg), HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40 | Secondary: Mean Change From Baseline in HbA1c (5 mg), HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with covariates Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|Mean Change From Baseline in Body Weight, LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates., Baseline, Week 40|Percentage of Participants Achieving an HbA1c Target Value of <7.0%, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing., Week 40|Percentage of Participants Achieving an HbA1c Target Value of <5.7%, HbA1c is the glycosylated fraction of hemoglobin A. Imputed data includes observed value and imputed value if endpoint measure is missing., Week 40|Mean Change From Baseline in Fasting Serum Glucose, Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates., Baseline, Week 40|Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values, The SMBG data was collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post-meal, Midday Premeal, Midday 2-hour Post-meal, Evening Premeal, Evening 2-hour Post-meal and Bedtime. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates., Baseline, Week 40|Percentage of Participants Who Achieved Weight Loss ≥5%, Imputed data includes observed value and imputed value if endpoint measure is missing., Week 40|Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score, DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures with Baseline + Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline OAM Use (Met, Met plus SU) + Treatment (Type III sum of squares) as covariates., Baseline, Week 40|Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia, The hypoglycemia events were defined by participant reported events with blood glucose \< 54 mg/dL \[\<3.0 Millimole per Liter (mmol/L)\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of post-baseline hypoglycemia was estimated by negative binomial model: Number of episodes = Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable., Baseline through end of safety follow-up (Up To Week 44)
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| Locations: |
Paratus Clinical Research Western Sydney, Blacktown, New South Wales, 2148, Australia|Paratus Clinical Research Central Coast, Kanwal, New South Wales, 2259, Australia|Holdsworth House Medical Practice, Sydney, New South Wales, 2010, Australia|Illawarra Shoalhaven Local Health District, Wollongong, New South Wales, 2500, Australia|Core Research Group, Milton, Queensland, 4064, Australia|Barwon Health - The Geelong Hospital, Geelong, Victoria, 3220, Australia|Adelaide Medical Solutions, Woodville South, 5011, Australia|Peking University People's Hospital, Beijing, Beijing, 100044, China|Huizhou Municipal Central Hospital, Huizhou, Guangdong, 516001, China|Cangzhou People's Hospital, Cangzhou, Hebei, 061600, China|Hebei Medical University, Hengshui Shi, Hebei, 053000, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|The First Affiliated Hospital of Henan University of Science &Technology, Luoyang, Henan, 471003, China|The Second Affiliated Hospital of Zhengzhou University, Zhengzhou Shi, Henan, 450014, China|The First People's Hospital of Yueyang, Yueyang, Hunan, 414000, China|Bao Tou Central Hospital, Bao Tou, Inner Mongolia, 014040, China|Changzhou No.2 People's Hospital, Changzhou, Jiangsu, 213003, China|Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210000, China|The First Hospital of Nanjing, Nanjing, Jiangsu, 210006, China|Zhongda Hospital Southeast University, Nanjing, Jiangsu, 210009, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|Nanjing Medical University - Nanjing Jiangning Hospital, Nanjing, Jiangsu, 211100, China|Suzhou Municipal Hospital, Suzhou, Jiangsu, 215002, China|The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215066, China|Wuxi People's Hospital, Wuxi, Jiangsu, 214023, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212000, China|The Third Hospital of Nanchang, Nanchang, Jiangxi, 330009, China|The First Hospital of Jilin University, Changchun, Jilin, 130021, China|Dalian University - The Affiliated Zhongshan Hospital, Dalian, Liaoning, 116001, China|Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China|First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, China|1st affiliated Hospital of Shanxi Medical University, Tai Yuan, Shan XI, 030001, China|Jinan Central Hospital, Jinan, Shandong, 250013, China|Qingdao Central Hospital, Qingdao, Shandong, 266042, China|Shanghai 6th people's hospital, Shanghai, Shanghai, China|The First Affiliated Hospital of Xi'an Medical University, XI 'an, Shanxi, China|West China Hospital Sichuan University, Chengdu, Sichuan, 610041, China|Chengdu Fifth People's Hospital, Chengdu, Sichuan, 611130, China|Tianjin Medical University General Hospital, Tianjin, Tianjin, 300052, China|Chongqing Three Gorges Central Hospital, Wanzhou, Wanzhou, 404199, China|Chongqing General Hospital, Chongqing, Yuzhong District, 400014, China|Huzhou Central Hospital, Huzhou, Zhejiang, 313000, China|Shaoxing People's Hospital, Shaoxing, Zhejiang, 312000, China|Beijing Peking Union Medical College Hospital, Beijing, 100730, China|Beijing Pinggu District Hospital, Beijing, 101200, China|Beijing Tsinghua Changgung Hospital, Beijing, 102202, China|Pingxiang People's Hospital, Pingxiang, 337000, China|Shanghai Putuo District Center Hospital, Shanghai, 200062, China|Tianjin People's Hospital, Tianjin, 300121, China|The Fourth People's Hospital of Zigong City, Zigong, China|King Edward Memorial Hospital and Research Center, Mumbai, Maharashtra, 400012, India|BSES Municipal General Hsptl, Mumbai, Maharashtra, 400058, India|Apollo Gleneagles Hospitals Kolkata, Kolkata, West Bengal, 700054, India|Fortis Hospital, Delhi, 110088, India|Kyung Hee University Hospital, Seoul, Gangdong-gu, 02447, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam, Geonggi-do, 13620, Korea, Republic of|Bucheon St. Mary's Hospital, Bucheon,, Gyeonggi-do, 14647, Korea, Republic of|Hanyang University Guri Hospital, Guri-si, Gyeonggido, 11923, Korea, Republic of|Yonsei University Wonju Severance Christian Hospital, Gangwon-do, Korea, 220-701, Korea, Republic of|Ulsan University Hospital, Ulsan, Korea, 44033, Korea, Republic of|Inje University Sanggye Paik Hospital, Seoul, Seoul-teukbyeolsi, 01757, Korea, Republic of|Korea University Anam Hospital, Seoul, Seoul-teukbyeolsi, 02841, Korea, Republic of|Keimyung University Dongsan Hospital, Daegu, Taegu-Kwangyǒkshi, 41931, Korea, Republic of|Korea University Ansan Hospital, Ansan-si, 15355, Korea, Republic of|Severance Hospital, Seoul, 03722, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of|Hallym University Kangnam Sacred Heart Hospital, Seoul, 07441, Korea, Republic of
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