NCT07003191进行中（未招募）不适用
Multicenter, Prospective, Observational Study of Metformin Hydrochloride and Empagliflozin Tablets (Enshuangping) in the Treatment of Type 2 Diabetes
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 2,600 人开始时间: 2023年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,600
- 试验地点
- 1
- 主要终点
- 6-month clinical glycemic control rate
研究概览
简要总结
The main objective of this study is to evaluate the efficacy and safety of Metformin Hydrochloride and Empagliflozin Tablets in the treatment of type 2 diabetes in real-world clinical settings. A total of 2,600 type 2 diabetes patients were included in the study. The study observed the clinical glycemic control rate and adverse events over a period of at least 6 months from the prescription date to the end of continuous clinical follow-up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, gender unrestricted;
- •Clinically diagnosed with type 2 diabetes;
- •First-time treatment with metformin and empagliflozin tablets;
- •HbA1c test results within 2 weeks prior to enrollment (rapid fingertip test results are acceptable);
- •Voluntary participation in the study and signing of informed consent form.
排除标准
- •Moderate to severe renal impairment (eGFR < 45 mL/min/1.73 m²), end-stage renal disease, or dialysis;
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
- •A history of severe allergy to empagliflozin, metformin, or any excipient in this product;
- •Currently or within the past month, participation in any other clinical trials;
- •Judged by the investigator to be unsuitable for participation in this study.
结局指标
主要结局
6-month clinical glycemic control rate
时间窗: 6 months
6-month clinical glycemic control rate (clinical control defined as HbA1c \< 7.0%)
次要结局
- Change in HbA1c from baseline(12 months)
- Change of β cell function(12 months)
- Change of insulin sensitivity(12 months)
- Change of body weight(12 months)
- Change of blood pressure(12 months)
- Change of Quality of life assessment (EQ-5D)(12 months)
- Incidence of adverse events(12 months)
- Change of lipid profiles(12 months)
- Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease(12 months)
研究者
Yanbing Li
the director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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