| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6, 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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement., Baseline and Month 6 | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics, 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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement., Baseline and Month 6|Percentage of Participants With a Decrease in HbA1c Level by <7.0%, Percentage of participants with a decrease of \<7.0% from baseline in HbA1c were reported., Baseline and Month 6|Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings, Percentage of participants with a decrease of \>0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%., Baseline and Month 6|Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time, The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement., Baseline and Months 3 and 6|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time, 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 Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement., Baseline and Months 3 and 6|Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs), An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI., Baseline up to Month 6|Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs, Months 3 and 6|Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction, Months 3 and 6
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| Locations: |
Beijing, Beijing, China|Wuhan, Hubei, China|Dalian, Liaoning, China|Shenyang, Liaoning, China|Jinan, Shandong, China|Qingdao, Shandong, China|Tai'an, Shandong, China|Taian, Shandong, China|Tianjin, Tianjin, China|Sai Ying Pun, Hong Kong|Sha Tin, Hong Kong
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