NCT01960179已完成3 期
An Open-label, Multicenter 24-Week And 52-Week Study Assessing The Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
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
- 361
- 试验地点
- 30
- 主要终点
- Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.
研究概览
简要总结
Primary Objective:
To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan
Secondary Objective:
To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on:
- HbA1c (Glycated hemoglobin A1c) reduction;
- Fasting plasma glucose;
- Body weight.
详细描述
- Group 1: 60 weeks ± 11 days
- Group 2: 32 weeks ± 7 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 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
lixisenatide
Experimental
lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment)
干预措施: lixisenatide AVE0010 (Drug)
结局指标
主要结局
Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.
时间窗: from baseline to 24 weeks and 52 weeks
次要结局
- Absolute change in body weight(from baseline to week 24 and week 52)
- Absolute change in HbA1c(from baseline to week 24 and week 52)
- Absolute change in fasting plasma glucose(from baseline to week 24 and week 52)
研究者
研究点 (30)
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