Effect of Exenatide Once Weekly on Cardiovascular Risk Markers in Patients With Type-2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subclinical atherosclerosis (as measured by cIMT) in patients with T2DM treated with exenatide once weekly
研究概览
简要总结
The glucagon-like peptide 1 (GLP-1) agonist exenatide represents an effective therapy in patients with type 2 diabetes mellitus (T2DM), which also seems to have some important non-glycemic effects. Yet, these non-glycemic effects are still largely unknown.
The effect of exenatide once weekly was investigated in controlled, blinded and open-label clinical studies in subjects with T2DM who were controlled on diet and exercise alone or in combination with oral antidiabetic agents, but also in multi-dose controlled studies and such studies resulted in significant reductions in glycemic parameters (mean glycated hemoglobin (HbA1c), fasting serum/plasma glucose as well as postprandial plasma glucose levels), but also in body weight, over 24 to 30 weeks. Meaningful reductions were observed as early as week 4 of treatment, and maintained through 6 years of treatment.
The study investigating cardiovascular effects of exenatide once weekly is currently undergoing. The results available are not numerous (such as DURATION-2, DURATION-3, DURATION-4 studies) and cannot lead to definitive conclusions.
In this study the investigators will evaluate the effect of exenatide once-weekly on multiple cardiovascular risk markers. These markers are related to subclinical atherosclerosis, endothelial dysfunction, oxidative stress and atherogenic lipoproteins.
The investigators will perform an open label, single-arm, prospective, intervention study using exenatide once weekly for a period of 8 months on 60 patients with T2DM.
详细描述
The research hypothesis is to assess whether exenatide once weekly can reduce subclinical atherosclerosis (as measured by carotid-intima media thickness [cIMT]) in patients with T2DM.
The primary objective is to assess whether exenatide once weekly can reduce subclinical atherosclerosis (as measured by cIMT) in patients with T2DM.
Primary endpoint: Reduction in cIMT. The secondary objective is to assess whether exenatide once weekly can reduce atherogenic lipoproteins, oxidative stress and endothelial dysfunction in patients with T2DM.
Secondary endpoint: Reduction in atherogenic lipoproteins, oxidative stress and improvement of endothelial dysfunction.
The purpose of the present 8 months study is to elucidate largely unknown non-glycemic effects of exenatide as add-on to metformin, including effects on cIMT, oxidative stress parameters and atherogenic lipoproteins, in addition to its benefit on glycemic control, weight loss and other efficacy parameters, as well as the safety profile of exenatide.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures;
- •Men and women with T2DM aged >18 years;
- •BMI >25 kg/m2;
- •HbA1c 7.5-8.5 %;
- •Receiving metformin therapy (doses ranging from 1500 to 3000 mg daily) for at least 8 weeks.
排除标准
- •Pregnancy or willingness to become pregnant;
- •Moderate and severe liver dysfunction;
- •Moderate and severe renal failure;
- •Previous major cardiovascular event;
- •Severe infections at the discretion of the investigator (such as human immunodeficiency virus [HIV], hepatitis B virus [HBV] and hepatitis C virus [HCV]);
- •Any malignancy;
- •Plasma triglycerides >400 mg/dL, plasma LDL-cholesterol > 250 mg/dL.
研究组 & 干预措施
60 patients with T2DM
These patients will be treated with exenatide once weekly for a period of 8 months
干预措施: Exenatide once weekly (BYDUREON™) (Drug)
结局指标
主要结局
Subclinical atherosclerosis (as measured by cIMT) in patients with T2DM treated with exenatide once weekly
时间窗: Change from baseline to 8 months of the treatment
Reduction in cIMT after 8 months of the treatment
次要结局
- Atherogenic lipoproteins (as measured by the analysis of 11 distinct lipoprotein subclasses using the Lipoprint system®) in patients with T2DM treated with exenatide once weekly(Change from baseline to 8 months of the treatment)
- Oxidative stress (as measured by markers of oxidative stress) in patients with T2DM treated with exenatide once weekly(Change from baseline to 8 months of the treatment)
- Endothelial dysfunction (as measured by flow mediated dilation of brachial artery) in patients with T2DM treated with exenatide once weekly(Change from baseline to 8 months of the treatment)
研究者
Manfredi Rizzo
Associate Professor
University of Palermo