NCT00268645已完成4 期
Open Trial of the Safety and Efficacy of Lantus for Insulin Naive Type 2 Diabetes Mellitus Patients or Patients Who Use Insulin Combined With 1 or More Oral Antidiabetic Drugs and Don't Have Good Glycemic Control.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- For efficacy: FBG (Fasting Blood Glucose), HbA1c
研究概览
简要总结
The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning Insulin glargine
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 2 Diabetes Mellitus patients,
- •Diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents,
- •Patients with HbA1C>8
- •Patients able to self-measure its blood glucose levels.
排除标准
- •According to package insert information (Summary of Product Characteristics)
结局指标
主要结局
For efficacy: FBG (Fasting Blood Glucose), HbA1c
次要结局
- For safety: ICA (Insulin Cell Antibody)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
OPAL - Insulin Glulisine, Diabetes MellitusDiabetes Mellitus Type 2NCT00272012Sanofi396
已完成
4 期
Insulin Glargine "All to Target" TrialDiabetes Mellitus, Type 2NCT00384085Sanofi588
已完成
不适用
Insulin Titration System Based on Deep LearningDiabetes Mellitus Type 2 - Insulin-TreatedNCT05409391Shanghai Zhongshan Hospital16
已完成
1 期
Lantus in PrediabetesDiabetes MellitusHyperglycemiaNCT00348972Sanofi20
已完成
3 期
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With PioglitazoneDiabetes Mellitus, Type 2NCT00996658Boehringer Ingelheim278