NCT00423215已完成不适用
An Open Therapeutic Observational Evaluation of the Efficacy and Safety Profile of Lantus in Everyday Medical Practice in Type 2 Diabetes Mellitus Patients, Who Start Receiving Lantus - Treated With Any Other Insulin, With A1c>7%
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
- Sanofi
- 入组人数
- 1,007
- 试验地点
- 1
- 主要终点
- Measure of Glycolysated Haemoglobin (HbA1c) level reduction
研究概览
简要总结
The objective of this protocol is to confirm the efficacy and safety profile of Lantus in every day medical practice, in type 2 diabetic patients, have been treated with any other insulin but who did not reach the target of A1c = 7%.
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
- •Patients with type 2 diabetes mellitus,
- •Having been treated with any other insulin, but who did not reach the target of A1c=7%.
- •Ability and willingness to perform Self Monitoring Blood Glucose measurement
排除标准
- •Will follow the prescribing information (Summary of Product Characteristics).
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Patients with Type II diabetes
干预措施: Insulin glargine (LANTUS) (Drug)
结局指标
主要结局
Measure of Glycolysated Haemoglobin (HbA1c) level reduction
时间窗: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)
次要结局
- Measure of Fasting Blood Glucose (FBG) level reduction(Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks))
- Investigator assessment(At the end of the study (i.e. 4 months +/- 2 weeks))
- Insulin dose(At the end of the study (i.e. 4 months +/- 2 weeks))
- Patient's satisfaction(At the end of the study (i.e. 4 months +/- 2 weeks))
研究者
研究点 (1)
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