Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 2
- 主要终点
- Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)
研究概览
简要总结
Primary Objective:
To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides.
Secondary Objectives:
The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation.
The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity.
The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.
详细描述
Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (Final/End-of-treatment Visit).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
lixisenatide
Lixisenatide injection should be performed in the morning, within 1 hour (ie, 0-60 minutes), prior to breakfast (or standardized meal).
Lixisenatide is to be started with once daily injections of 10 μg per day for 2 weeks then to be continued by the maintenance dose (8 weeks) of 20 μg/d up to the end of the treatment period.
干预措施: LIXISENATIDE AVE0010 (Drug)
lixisenatide
Lixisenatide injection should be performed in the morning, within 1 hour (ie, 0-60 minutes), prior to breakfast (or standardized meal).
Lixisenatide is to be started with once daily injections of 10 μg per day for 2 weeks then to be continued by the maintenance dose (8 weeks) of 20 μg/d up to the end of the treatment period.
干预措施: metformin (Drug)
结局指标
主要结局
Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)
时间窗: After 10 weeks of treatment
次要结局
- Change from baseline in plasma cholesterol(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in insulin(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in free fatty acid levels(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in lipoprotein distribution(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in plasma triglyceride(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in LDL oxidation(2 days after the basal test and after 10 weeks of treatment)
- Change in baseline coronary flow reserve to assess the effect of lixisenatide on microvascular dysfunction(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in APO B48(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in postprandial plasma glucose(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in C-peptide(2 days after the basal test and after 10 weeks of treatment)
- Change from baseline in low grade inflammation (cytokines and stress oxidative markers)(2 days after the basal test and after 10 weeks of treatment)