Retrospective Study to Evaluate the Safety of Duvie 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
- 2,228
- 试验地点
- 1
- 主要终点
- Incidence of major adverse events (AEs) and any AEs that occurred during the administration period of lobeglitazone
研究概览
简要总结
Previous thiazolidinediones (TZDs) have issued various safety concerns including weight gain, bladder cancer, and congestive heart failure (CHF). This study aimed to evaluate the efficacy and safety of lobeglitazone, a novel TZD in patients with type 2 diabetes in real world.
详细描述
Lobeglitazone have clinical trials conducted in Korean type 2 diabetics patients for 6 months to up to 12 months, and the results of study on the efficacy and safety of lobeglitazone are relatively limited. In pre-marketing clinical trials, a controlled group of patients is enrolled to minimize other possible effects in determining the efficacy and safety of the drug.
Consequently, in real clinical practice, unexpectable safety information that has not been discovered at the pre-marketing stage may accur because it is more extensively and longer administered to a variety of patients who may have various underlying conditions and diseases. Therefore, there should be an ongoing assessment of safety information in real world. There have been the safety concerns of TZD, such as congestive heart failure (CHF), fractures, bladder cancer (long-term use), edema, and weight gain. Previous study has reported that lobeglitazone has better safety on bladder cancers and bone fractures than other TZDs, but currently, there is a lack of large-scaled, long-term safety and efficacy data of lobeglitazone in Korean real practice.
This is a non-interventional, multi-centered, retrospective and observational study and aimed to evaluate the efficacy and safety of lobeglitazone in patients with type 2 diabetes in real world.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 2 diabetes who received lobeglitazone 0.5mg for more than one year between February 1, 2014 and December 20, 2018
排除标准
- •patients who are not appropriate to participate in this research based on principal investigators' decision
研究组 & 干预措施
Duvie(Lobeglitazone)
patients with type 2 diabetes who received lobeglitazone 0.5mg for more than one year between February 1, 2014 and December 20, 2018
干预措施: Duvie(Lobeglitazone) tab 0.5mg (Drug)
结局指标
主要结局
Incidence of major adverse events (AEs) and any AEs that occurred during the administration period of lobeglitazone
时间窗: during the administration period of lobeglitazone
Investigators identified the following as major AEs: edema, weight gain(in kilograms), fractures, bladder cancer, anemia, hypoglycemia, macular edema, cardiac death, myocardial Infarction, stroke, transient ischemic attack, coronary arterial occlusion, and CHF. Investigators also identified any AEs including blood pressure(in millimeter of mercury) change, increased liver enzyme (\> 3X), and dizziness.
次要结局
- Changes in glycated hemoglobin (HbA1c) and glucose, lipid parameters(3, 6, 12, 18, 24, 36, 42, and 48 months after administration of lobeglitazone)