NCT01081938终止4 期
National, Phase IV, Multicentric, Open Label, Comparative Study to Evaluate the Efficacy and Safety of Insulin Glargine Plus Glulisine and Sliding Scale Plus Glulisine in Hospitalized Patients With Diabetes Metabolism Type II Under Enteral Nutrition.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 15
- 试验地点
- 10
- 主要终点
- Glycaemic parameters assessment
研究概览
简要总结
Primary Objective:
1- Proportion of patients with mean daily glycemia <140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale.
Secondary Objective:
- Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period.
- Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period.
- Incidence of severe hyperglycemia (>400mg/dL) during the treatment period.
- Total dose of insulin and correction dose in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Insulin Glargine + Insulin Glulisine
干预措施: INSULIN GLARGINE (Drug)
1
Experimental
Insulin Glargine + Insulin Glulisine
干预措施: INSULIN GLULISINE (Drug)
2
Active Comparator
Insulin Glulisine
干预措施: INSULIN GLULISINE (Drug)
结局指标
主要结局
Glycaemic parameters assessment
时间窗: During the period of 7 Days of treatment
次要结局
- Incidence of moderate and severe hyperglycemia(During the period of 7 Days of treatment)
- Incidence of symptomatic, nocturnal and severe hypoglycemias(During the period of 7 Days of treatment)
研究者
研究点 (10)
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