Outcome Measures: |
Primary: Percentage of Participants With Serious Adverse Events (SAEs), An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 95% Confidence Interval was calculated using exact method., From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)|Percentage of Participants With Serious Adverse Drug Reactions (ADRs), Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 95% Confidence Interval was calculated using exact method., From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)|Percentage of Participants With Unexpected Adverse Events, An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. 95% Confidence Interval was calculated using exact method., From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)|Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs), Unexpected ADRs are unexpected AEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method., From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) | Secondary: Haemoglobin (HbA1c) Levels, HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin., Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration|Fasting Blood Glucose Levels, Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration|Percentage of Participants With HbA1c < 7.00%, HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin., Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration|Percentage of Participants With Overall Improvement and Final Effectiveness Assessment, Participants were assessed for overall improvement and effectiveness assessments as per the following categories: 'Improved - signs and symptoms are significantly improved'; 'Unchanged - improvement in signs and symptoms is not significant or there is no change in signs and symptoms'., Up to Week 26
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Locations: |
Andong, Korea, Republic of|Anyang-si, Korea, Republic of|Bucheon-si, Korea, Republic of|Busan, Korea, Republic of|Daegu, Korea, Republic of|Daejeon, Korea, Republic of|Gimhae, Korea, Republic of|Gongju, Korea, Republic of|Goyang-si, Korea, Republic of|Gwangju, Korea, Republic of|Gyeongju, Korea, Republic of|Incheon, Korea, Republic of|Jeonju, Korea, Republic of|Namyangju-si, Korea, Republic of|Osan, Korea, Republic of|Seongnam-si, Korea, Republic of|Seongnam, Korea, Republic of|Seoul, Korea, Republic of|Suncheon, Korea, Republic of|Suwon- si, Korea, Republic of|Suwon-si, Korea, Republic of|Ulsan, Korea, Republic of|Wonju, Korea, Republic of
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