NCT01077570已完成不适用
The Clinical Safety and Effectiveness of Repaglinide in Treatment-naive Type 2 Diabetes Subjects in China. A 16-week Multicentre, Prospective, Open Label, Non-interventional Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,033
- 主要终点
- Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese patients with type 2 diabetes who have never received anti-diabetic treatment before.
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
- •HbA1c more than 6.5%, no anti-diabetes treatment accepted before entering the study
排除标准
- •Subjects who received any anti-diabetic treatment previously
- •Known or suspected allergy to trial product(s) or related products.
- •Subjects who previously enrolled in this study.
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
研究组 & 干预措施
Repaglinide
干预措施: repaglinide (Drug)
结局指标
主要结局
Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events
时间窗: at Visit 2(8 weeks) and visit 3(16 weeks)
次要结局
- Number of minor hypoglycaemic (low blood sugar) episodes(at Visit 2(8 weeks) and visit 3(16 weeks))
- Number of adverse drug reactions (ADRs)(at Visit 2(8 weeks) and visit 3(16 weeks))
- Change in HbA1c(after 16 weeks of treatment)
- Change in postprandial blood glucose (PBG)(after 8 and 16 weeks treatment)
- Change in fasting blood glucose (FBG)(after 8 and 16 weeks of treatment)
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