NCT00467376已完成3 期
12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- Hypoglycemic episodes
研究概览
简要总结
Primary:
- To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
- To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.
Secondary:
- To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetic patients
- •Measure HbA1c 6.5% to 11.0% at visit 1
- •More than 3 months of continuous insulin treatment immediately prior to study entry
排除标准
- •Pregnant women
- •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
1
Experimental
Administration of Insulin Glulisine
干预措施: Insulin Glulisine (Drug)
1
Experimental
Administration of Insulin Glulisine
干预措施: Insulin Glargine (Drug)
2
Active Comparator
Administration of Lispro
干预措施: Lispro (Drug)
2
Active Comparator
Administration of Lispro
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Hypoglycemic episodes
时间窗: From the beginning to end of the study
Change in HbA1c
时间窗: From baseline to endpoint
Adverse events
时间窗: From the beginning to the end of study
次要结局
- Change in HbA1c(From baseline to weeks 12)
- blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.(from baseline to week 12)
研究者
研究点 (1)
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不适用
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