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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04980040
Other study ID # Alogliptin-6001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 19, 2014
Est. completion date August 30, 2019

Study information

Verified date March 2022
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected in the precautions for use, ADRs already known, non-serious ADRs and other safety related information among participants who have received alogliptin for type 2 diabetes mellitus.


Description:

This is a long-term prospective, observational post-marketing surveillance study of alogliptin in participants with T2DM. The study assessed the safety and effectiveness of alogliptin for its approved indication within a real-world setting in South Korea. The study will enroll approximately 3000 participants. The data is collected prospectively at the study sites and recorded in electronic case report forms (e-CRFs). All the participants are assigned to a single observational cohort: • Nesina® Tablet The multi-center study is conducted in South Korea. Data is collected at 13 and 26 weeks after enrollment during standard of care office visits. The overall study was conducted during re-examination period of approximately 5 years and 4 months.


Recruitment information / eligibility

Status Completed
Enrollment 3623
Est. completion date August 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Had one of the following treatments with alogliptin for the first time as an adjunct to diet and exercise to improve glycemic control: - Monotherapy with alogliptin - Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with metformin or sulfonylurea or thiazolidinedione single therapy - Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with thiazolidinedione and metformin combination therapy - Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with insulin (single therapy or combination with metformin) therapy - Combination therapy with metformin in patients who have no prior history of antidiabetic medication and may not achieve adequate glycemic control with monotherapy alogliptin Exclusion Criteria: 1. Had alogliptin treatment outside of the locally approved label in Korea 2. Had a contraindication for the use of alogliptin (as described in the Korean product label)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Alogliptin Benzoate
Alogliptin benzoate tablets

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
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)
Primary 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)
Primary 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)
Primary 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
Secondary Fasting Blood Glucose Levels Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
Secondary 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
Secondary 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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