Restoration of First Phase Insulin Release in Subjects With Type 2 Diabetes Mellitus With Subcutaneous Injection of 20 µg AVE0010 in a Double-blind, Randomized, Placebo-controlled, Two-way Cross Over Intravenous Glucose Challenge Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Area under the insulin secretion curve
研究概览
简要总结
The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin
- •HbA1c>=6,0 % and <=8,5 % at screening
- •BMI 25 to 35 kg/m²
- •155>=BP systolic >=90 mmHg
- •100>=BP diastolic>=45 mmHg
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Sequence 1: AVE0010/Placebo
Period 1: lixisenatide 20 µg in 200 µL, one single dose
Period 2: placebo 200 µL, one single dose
干预措施: Lixisenatide (AVE0010) (Drug)
Sequence 1: AVE0010/Placebo
Period 1: lixisenatide 20 µg in 200 µL, one single dose
Period 2: placebo 200 µL, one single dose
干预措施: Placebo (Drug)
Sequence 2: Placebo/AVE0010
Period 1: placebo 200 µL, one single dose
Period 2: lixisenatide 20 µg in 200 µL, one single dose
干预措施: Lixisenatide (AVE0010) (Drug)
Sequence 2: Placebo/AVE0010
Period 1: placebo 200 µL, one single dose
Period 2: lixisenatide 20 µg in 200 µL, one single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the insulin secretion curve
时间窗: within 10 minutes after I.V. glucose challenge
次要结局
- Area under the insulin secretion curve(within 10 to 120 minutes after I.V. glucose challenge)