An Open-Label, Multicenter 52-Week Study Assessing the Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 294
- 试验地点
- 27
- 主要终点
- Safety over 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:
The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan.
Secondary Objective:
To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on:
- HbA1c;
- Fasting plasma glucose;
- Body weight.
详细描述
54 weeks +/-11 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lixisenatide + Biguanide
52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
干预措施: lixisenatide AVE0010 (Drug)
Lixisenatide + Biguanide
52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
干预措施: biguanide (Drug)
Lixisenatide + TZD
52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
干预措施: lixisenatide AVE0010 (Drug)
Lixisenatide + TZD
52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
干预措施: TZD (Drug)
Lixisenatide + alpha-GI
52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
干预措施: lixisenatide AVE0010 (Drug)
Lixisenatide + alpha-GI
52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
干预措施: alpha-GI (Drug)
Lixisenatide + Glinide
52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
干预措施: lixisenatide AVE0010 (Drug)
Lixisenatide + Glinide
52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
干预措施: glinide (Drug)
结局指标
主要结局
Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data
时间窗: 52 weeks
次要结局
- Absolute change in body weight(From baseline to weeks 24 and 52)
- Absolute change in HbA1c(From baseline to weeks 24 and 52)
- Absolute change in fasting plasma glucose(From baseline to weeks 24 and 52)