NCT00806936已完成不适用
A 16-week Multicentre, Open Label, Non-interventional, Observational Study to Investigate the Status of Human Insulin or Insulin Analogue Treatments With Focusing on Efficacy and Safety in Type 2 Diabetes Subjects Inadequately Controlled With Two or More Oral Antidiabetic Drugs in China
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
- 4,847
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving HbA1c below 7.0%
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic drugs in China. Further the safety profiles will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study
- •The selection of the subjects will be at the discretion of the individual investigator
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Subjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
- •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
- •The receipt of any investigational product within 3 months prior to this trial
研究组 & 干预措施
A
干预措施: human insulin (Drug)
B
干预措施: insulin analogue (Drug)
结局指标
主要结局
Percentage of patients achieving HbA1c below 7.0%
时间窗: at 16 weeks
次要结局
- HbA1c change from baseline(at 16 weeks)
- Comparison of scores of Insulin Treatment Appraisal Scale (ITAS)(at baseline and at 16 weeks)
- Incidence of major, minor and symptoms only hypoglycaemic episodes(at 16 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Safety and Efficacy Study of NovoRapid™ in Patients With Coexisting Diabetes and Kidney DiseaseDiabetesChronic Kidney DiseaseDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1NCT00849316Novo Nordisk A/S
已完成
不适用
An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalised SubjectsDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2NCT00700648Novo Nordisk A/S3,024
已完成
不适用
Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 DiabetesDelivery SystemsDiabetesDiabetes Mellitus, Type 2NCT00715663Novo Nordisk A/S1,584
已完成
不适用
Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™Delivery SystemsDiabetes Mellitus, Type 2DiabetesDiabetes Mellitus, Type 1NCT00675220Novo Nordisk A/S373
已完成
不适用
Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical PracticeDiabetes Mellitus, Type 2DiabetesNCT01492166Novo Nordisk A/S1,935