NCT00633425已完成4 期
Continuous Glucose Monitoring System (CGMS) in Type 2 Diabetic Patients Inadequately Controlled by Metformine Monotherapy; Analyze of Glycemic Profile Before and After Association of Glimepiride
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
- 43
- 试验地点
- 1
- 主要终点
- Change in interstitial glucose levels between the observation and maintenance phases.
研究概览
简要总结
Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 35 to 70 years
- •Having given their consent
- •Type 2 diabetics (HBA1c greater than 6.5%
- •Fasting glycaemia greater than 1.40 g/l) not controlled by Metformin for at least 6 weeks.
排除标准
- 未提供
结局指标
主要结局
Change in interstitial glucose levels between the observation and maintenance phases.
时间窗: The mean of 24 variations in average hourly glucose readings recorded by CGMS.
次要结局
- HbA1c and fasting blood glucose levels.(Measured in the observation and maintenance phases, and change between the two phases.)
研究者
研究点 (1)
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