A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,024
- 试验地点
- 1
- 主要终点
- Incidences of ADRs and SAEs
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin.
详细描述
This study adopts a multicenter, prospective, and observational cohort study design and does not involve randomization, control, and blinding. Patients with type 2 diabetes mellitus who were prescribed Dorzagliatin according to the package insert and physician's judgment in routine medical practice setting will be included, and the data of these patients during 52-week Dorzagliatin treatment will be collected to evaluate the safety of long-term medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for this study:
- •Male or female ≥ 18 years of age at the time of signing the informed consent form;
- •Patients with type 2 diabetes mellitus diagnosed at screening;
- •Patients who have been prescribed Dorzagliatin according to the package insert and physician's judgment (the prescription should be made before enrolling the patient in this study and is independent of the enrollment decision);
- •Willingness to participate in the study and sign written informed consent.
排除标准
- •Patients will not be eligible if they meet any of the following criteria:
- •Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes;
- •Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin;
- •Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.
研究组 & 干预措施
Dorzagliatin group
Dorzagliatin tablet (75 mg, BID) treatment for 52 weeks
干预措施: Dorzagliatin tablets (Drug)
结局指标
主要结局
Incidences of ADRs and SAEs
时间窗: 52 weeks
The incidences of adverse drug reactions (ADRs) and serious adverse events (SAEs) as well as ADRs of special interest during the 52-week observation period of Dorzagliatin treatment.
次要结局
- Response rate(52 weeks)
- Blood glucose indicators(52 weeks)