| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination), The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control., Baseline and Week 26 (or Early termination) | Secondary: Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20, The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 4, 8, 12, 16 and 20 relative to baseline. Negative change indicates better glycemic control., Baseline and Weeks 4, 8, 12, 16 and 20|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26, The change between the FPG value collected at Weeks 4, 8, 12, 16, 20 and 26 relative to baseline. Negative change indicates better glycemic control., Baseline and Weeks 4, 8, 12, 16, 20 and 26|Time to Hyperglycemic Rescue Event, Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After \>1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline. Time to hyperglycemic rescue was censored if the participant did not experience a hyperglycemic rescue event., From the date of randomization through Week 26|Percentage of Participants Requiring Hyperglycemic Rescue, Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After \>1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline., Baseline up to Week 26|Percentage of Participants With Marked Hyperglycemia, Marked hyperglycemia is defined as FPG level ≥200 mg/dL (11.1 mmol/L)., Baseline up to Week 26|Change From Baseline in Body Weight at Weeks 12 and 26, Change in participant's body weight at Weeks 12 and 26 relative to baseline., Baseline and Weeks 12 and 26|Percentage of Participants With Glycosylated Hemoglobin ≤6.5%, Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤6.5%., Week 26|Percentage of Participants With Glycosylated Hemoglobin ≤7.0%, Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7%., Week 26|Percentage of Participants With Glycosylated Hemoglobin ≤7.5%, Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7.5%., Week 26|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%, Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥0.5%., Baseline and Week 26|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%, Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.0%., Baseline and Week 26|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%, Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.5%., Baseline and Week 26|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%, Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥2.0%., Baseline and Week 26
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| Locations: |
Beijing, Beijing, China|Fuzhou, Fujian, China|Xiamen, Fujian, China|Guangzhou, Guangdong, China|Nanning, Guangxi, China|Guiyang, Guizhou, China|Hengshui, Hebei, China|Shijiazhuang, Hebei, China|Shiyan, Hubei, China|Wuhan, Hubei, China|Changsha, Hunan, China|Yueyang, Hunan, China|Changzhou, Jiangsu, China|Nanjing, Jiangsu, China|Suzhou, Jiangsu, China|Nanchang, Jiangxi, China|Changchun, Jilin, China|Shenyang, Liaoning, China|Xi'an, Shanxi, China|Chengdu, Sichuan, China|Wenzhou, Zhejiang, China|Beijing, China|Shanghai, China|Tianjin, China|Goyang-si, Gyeonggi-do, Korea, Republic of|Seongnam-si, Gyeonggi-do, Korea, Republic of|Suwon, Gyeonggi-do, Korea, Republic of|Busan, Korea, Republic of|Seoul, Korea, Republic of|Johor Bahru, Johor, Malaysia|Alor Setar, Kedah Darul Aman, Malaysia|Alor Setar, Kedah, Malaysia|Kubang Kerian, Kelantan, Malaysia|Nilai, Negeri Sembilan, Malaysia|Seremban, Negeri Sembilan, Malaysia|Tampin, Negeri Sembilan, Malaysia|Bagan Serai, Perak, Malaysia|Ipoh, Perak, Malaysia|Petaling Jaya, Selangor, Malaysia|Shah Alam, Selangor, Malaysia|Putrajaya, WIlayah Persekutuan, Malaysia|Kaohsiung, Taiwan|New Taipei City, Taiwan|Taichung, Taiwan|Taipei, Taiwan
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