Multi-center, Single-group, Prospective Observational Study to Evaluate the Efficacy of DEXINEURO Tab on Blood Glucose Reduction in Type 2 Diabetic Patients With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline
研究概览
简要总结
This study is to evaluate the efficacy of DEXINEURO® tab on blood glucose reduction and assess the interaction with concomitantly administered insulin or oral antidiabetic agents in patients with type 2 diabetes accompanied by diabetic peripheral neuropathy.
详细描述
This clinical trial is a multi-center, single-group, prospective observational study conducted to investigate the interaction with concomitant insulin or oral antidiabetic agents and assess the influence on blood glucose reduction when administering DEXINEURO® tab to patients with type 2 diabetes and diabetic peripheral neuropathy.
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
- •Adults aged 19 years and older of both genders.
- •Type 2 diabetes patients with HbA1c ≤ 10% at screening.
- •Patients diagnosed with diabetic peripheral neuropathy who are scheduled to receive DEXINEURO® tab.
- •Individuals who have voluntarily provided written consent to participate in this study.
排除标准
- •Individuals who have taken or are currently taking alpha-lipoic acid (thioctic acid) within 1 month before screening.
- •Individuals contraindicated according to the approval conditions of DEXINEURO® tab.
- •Pregnant or breastfeeding women.
- •Individuals participating in other clinical trials (except for non-interventional observational studies, if they have not received investigational drugs, or are participating in other non-interventional observational studies).
- •Individuals whom the principal investigator deems inappropriate for participation in this study for reasons other than those mentioned above.
结局指标
主要结局
Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline
时间窗: after 12 weeks of prescription for DEXINEURO tab compared to baseline
Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline
次要结局
未报告次要终点