A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE DUO® (Empagliflozin/Metformin, 5/500mg, 5/850mg, 5/1000mg, 12.5/500mg, 12.5/850mg, 12.5/1000mg) 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
- 658
- 试验地点
- 20
- 主要终点
- Percentage of Participants With Any Adverse Events
研究概览
简要总结
To monitor the safety profile and effectiveness of JARDIANCE DUO® 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
- Case Only
- 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 JARDIANCE DUO® 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 JARDIANCE®, JARDIANCE DUO®
- •Hypersensitivity to active ingredients empagliflozin and/or metformin or to any of the excipients
- •Moderate (stage 3b) and severe renal failure (CrCl < 45 ml/min or eGFR < 45 ml/min/1.73 square meter)
- •Acute conditions with the potential to alter renal function such as: dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, sepsis
- •Type1 diabetes, acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, history of a ketoacidosis (type 1 diabetes and diabetic ketoacidosis should be treated with insulin).
- •Congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure
- •Radiologic studies involving the use of intravascular iodinated contrast materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials)
- •Intravascular administration of iodinated contrast media may lead to acute renal failure and has been associated with lactic acidosis in patients receiving metformin.
- •Therefore, in patients with eGFR > 60ml/min/1.73m2, JARDIANCE DUO® must be discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further. In patients with moderate renal impairment (eGFR 45-60 ml/min/1.73m2), JARDIANCE DUO® must be discontinued 48 hours before administration of iodinated contrast media and not be reinstituted until at least 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further.
- •In patients with severe infections or severe traumatic systemic disorders, JARDIANCE DUO® should be temporarily suspended, and should not be restarted until the patient's oral intake has resumed and renal function has been evaluated as normal.
- •JARDIANCE DUO® should be temporarily suspended for any surgical procedure(except minor procedures not associated with restricted intake of food and fluids)before 48 hours, and not be reinstituted until 48 hours afterwards, after renal function has been evaluated as normal.
- •Patients with malnutrition, starvation, hypostheniam pituitary or adrenal insufficiency
- •Impaired hepatic function (since impaired hepatic function has been associated with some cases of lactic acidosis, JARDIANCE DUO® should generally be avoided in patients with clinical or laboratory evidence of hepatic disease), pulmonary infarction, severe respiratory impairment, any condition associated with hypoxemia, excessive alcohol intake, GI disorders such as dehydration, diarrhoea or vomiting
- •Pregnant women, women who may be pregnant, nursing women
- •Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
- •Current participation in other clinical trials
研究组 & 干预措施
Subjects diagnosed with type 2 diabetes mellitus
干预措施: JARDIANCE DUO® (Drug)
结局指标
主要结局
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 received during the study), up to 349 days.
Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method.
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 received during the study), up to 349 days.
Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse event 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 received during the study), up to 349 days.
Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse event 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 received during the study), up to 349 days.
Percentage of participants with adverse events of special interest was reported. The 95% Confidence Interval for the percentage of participants with adverse event 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 received during the study), up to 349 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 event was calculated by Exact Method.
次要结局
- Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline(At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).)
- Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit(At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).)
- Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit(At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).)
- Change in the Fasting Plasma Glucose (FPG) at Last Visit From Baseline(At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).)
- Change in the Body Weight at Last Visit From Baseline(At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).)
- Change in the Systolic Blood Pressure (SBP) at Last Visit From Baseline(At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).)
- Change in the Diastolic Blood Pressure (DBP) at Last Visit From Baseline(At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).)
- Number of Participants Per Final Effectiveness Assessment Category at Last Visit(At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).)