NCT01588639已完成不适用
A Prospective Multi-centre, Non-randomized, Open-label, Non-interventional Study to Evaluate the Safety, Efficacy and Injection Compliance of Scilin N, Scilin R or Scilin M30 in Chinese Type 2 Diabetes Mellitus (T2DM)
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
- 发起方
- Bayer
- 入组人数
- 2,683
- 主要终点
- Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events
研究概览
简要总结
This is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. The term study insulins will be used in this protocol for these drugs and combinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Based on physicians' clinical judgement, subjects who are treated with SciLin N, SciLin R and SciLin M30 ( alone or in combination) will be eligible to be included in this clinical study.
排除标准
- •Subjects with one of the conditions listed below will be excluded:
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months Subjects who have to be treated with other insulins simultaneously Subjects who are participating in other diabetes clinical studies at the same time
研究组 & 干预措施
Group 1
干预措施: Insulin (Scilin R _BAY81-9924 (Drug)
Group 1
干预措施: Insulin (Scilin N, BAY81-9924) (Drug)
Group 1
干预措施: Insulin(Scilin M30_BAY81-9924) (Drug)
结局指标
主要结局
Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events
时间窗: up to 12 week
次要结局
- Occurrence rate of hypoglycemic events(up to 12 weeks)
- Change in HbA1c(Baseline and week 12)
- Change in FPG (Fasting Plasma Glucose)(Baseline and week 12)
- Change in PPG (Postprandial Glucose)(Baseline and week 12)
- The ratio of compliance injection (following physician's advice)(up to 12 weeks)
- Number and ratio of missed injections(up to 12 weeks)
研究者
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