Post Marketing Surveillance Protocol for Nesina® Tablet [Monotherapy or Combination Therapy in Type 2 Diabetic Patients]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,623
- 主要终点
- Percentage of Participants With Serious Adverse Drug Reactions (ADRs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Nesina® Tablet
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, are observed in this study.
干预措施: Alogliptin Benzoate (Drug)
结局指标
主要结局
Percentage of Participants With Serious Adverse Drug Reactions (ADRs)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Percentage of Participants With HbA1c < 7.00%(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(Up to Week 26)
- Haemoglobin (HbA1c) Levels(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)