A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE® (Empagliflozin, 10mg, 25mg, q.d.) 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
- 3,368
- 主要终点
- Percentage of Participants With Adverse Events Relating to Study Drug
研究概览
简要总结
To monitor the safety profile and effectiveness of Empagliflozin in Korea 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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
JARDIANCE
T2DM with JARDIANCE
干预措施: JARDIANCE 10mg (Drug)
JARDIANCE
T2DM with JARDIANCE
干预措施: JARDIANCE 25mg (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events Relating to Study Drug
时间窗: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug
时间窗: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Percentage of Participants With Any Adverse Events
时间窗: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Percentage of Participants With Unexpected Adverse Events
时间窗: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Percentage of Participants With Adverse Events of Special Interest
时间窗: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: * Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection * Increased urination * Urinary tract infection (UTI) * Volume depletion * Diabetic Ketoacidosis (DKA) * Decreased renal function: * Hepatic injury * Lower limb amputation
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit(At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).)
- Change From Baseline in Body Weight at Last Visit(At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit(At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).)
- Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit(At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).)
- Number of Participants Per Final Effectiveness Assessment Category at Last Visit(At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).)
- Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit(At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).)
- Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit(At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).)
- Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit(At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).)