NCT00397553已完成3 期
Multicenter, Open, Non-randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also 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
- 104
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy
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
- •Diabetes mellitus, Type 1
- •HbA1c 6.5-11.0%
- •BMI <35 kg/m²
排除标准
- •Diabetes mellitus, Type 2
- •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
Insulin Glulisine
Experimental
干预措施: Insulin glulisine (Drug)
结局指标
主要结局
HbA1c
时间窗: 52 weeks
次要结局
- HbA1c(26 weeks)
- Fasting Blood Glucose(52 weeks)
- Post-prandial glycemia (2 hour after breakfast)(52 weeks)
研究者
研究点 (1)
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