A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Esgliteo (Empagliflozin/Linagliptin, 10/5mg, 25/5mg) in Korean Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,053
- 试验地点
- 30
- 主要终点
- All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®
研究概览
简要总结
The objectives of this study are to monitor the safety and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.
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
- •Patients who have started at first time on Esgliteo in accordance with the approved label in Korea
- •Age ≥19 years at enrolment
- •Patients who have signed on the data release consent form
排除标准
- •Patients with previous exposure to Esgliteo
- •Patients with hypersensitivity to the empagliflozin and/or linagliptin or any of the excipients
- •Patients with type 1 diabetes or diabetic ketoacidosis
- •Patients with estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73m2, end stage renal disease, or patient on dialysis
- •Patients for whom empagliflozin/linagliptin is contraindicated according to the local label of Esgliteo
研究组 & 干预措施
Patients diagnosed with type 2 diabetes mellitus
Patients aged 19 years or older, diagnosed with type 2 diabetes mellitus in Korea, who initiated treatment with ESGLITEO® for the first time in accordance with the locally approved label.
干预措施: Empagliflozin/Linagliptin (Drug)
结局指标
主要结局
All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®
时间窗: From first trial drug administration up to 24 weeks.
These include those who signed the data release consent form to participate in this study as subject, took Esgliteo once at least, and were followed up by the physician once or more.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment
时间窗: From the first trial drug administration up to 24 weeks.
The mean change from baseline in glycosylated hemoglobin (HbA1c) after 24 weeks of treatment is presented.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment
时间窗: From the first trial drug administration up to 12 weeks.
The mean change from baseline in glycosylated hemoglobin (HbA1c) after 12 weeks of treatment is presented.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)
- Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)
- Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)
- Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)
- Change From Baseline in Body Weight After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Change From Baseline in Body Weight After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)