A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea
- Registration Number
- NCT04980040
- Lead Sponsor
- Takeda
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3623
- 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
- Had alogliptin treatment outside of the locally approved label in Korea
- Had a contraindication for the use of alogliptin (as described in the Korean product label)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Nesina® Tablet Alogliptin Benzoate Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, are observed in this study.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Serious Adverse Drug Reactions (ADRs) From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) 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.
Percentage of Participants With Serious Adverse Events (SAEs) From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) 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.
Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs) From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) 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.
Percentage of Participants With Unexpected Adverse Events From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HbA1c < 7.00% Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Percentage of Participants With Overall Improvement and Final Effectiveness Assessment Up to Week 26 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'.
Haemoglobin (HbA1c) Levels Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Fasting Blood Glucose Levels Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration