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Clinical Trial Details

Trial ID: L5916
Source ID: NCT04980040
Associated Drug: Alogliptin Benzoate
Title: A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04980040/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Alogliptin Benzoate
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
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 3623
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2014-04-19
Completion Date: 2019-08-30
Results First Posted: 2022-04-05
Last Update Posted: 2022-04-05
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
URL: https://clinicaltrials.gov/show/NCT04980040