An Observational Study to Evaluate Cardiovascular Outcomes of Patients With Type 2 Diabetes Mellitus Treated With Gemigliptin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,180
- 试验地点
- 1
- 主要终点
- Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint
研究概览
简要总结
The primary objective of the study is to investigate cardiovascular safety of gemigliptin by evaluating the time until patients report with major adverse cardiovascular events (MACE) in T2DM patients treated with gemigliptin.
Study patients will be followed up to 4 years until MACE occurrence or until the patient drops out of the study or completion of the study. The patient who switches to a non-gemigliptin treatment after initiating gemigliptin therapy will be followed until MACE occurrence or until the patient drops out of the study or completion of the study.
The secondary objectives of the study are to evaluate adverse events related as well as not-related to MACE in diabetic patients treated with gemigliptin.
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
- •Female or male patients, who are ≥ 19 years, with diagnosis of T2DM
- •Diabetic patients whose condition cannot be adequately controlled by on-going dietary and/or under antidibatetic treatment are decided to prescribe gemigliptin according to the physician's judgment
- •Patients must be willing and able to provide written informed consent form to use of personal information as well as the guardian's contact information and the permission to contact with the guardian in case the patient cannot be contacted.
排除标准
- •Patients with T1DM
- •Patients who experienced an acute coronary syndrome (ST-elevation myocardial infarction and non- ST elevation myocardial infarction) or ischemic stroke within the last 3 months before enrolment OR patients who have been treated with dipeptidyl peptidase IV (DPP-4) inhibitors or glucagon-like peptide (GLP-1) analogues for 3 months before enrolment.
- •Patients with a diagnosis of severe or end-stage heart failure (New York Heart Association class III or IV).
- •Patients who are currently participating or plan to participate in any interventional clinical trial
- •Patients who are not prescribed gemigliptin or with counterindications for gemigliptin
- •Patients who are considered not fit for the study by physician
研究组 & 干预措施
Type 2 Diabetes Mellitus
干预措施: gemigliptin (Drug)
结局指标
主要结局
Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint
时间窗: during the study period (2~4 years)
次要结局
未报告次要终点