NCT00948168已完成4 期
6-Months Exenatide and Glucose Homeostasis Determinants in Type 2 Diabetic Patients
Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Improvement in HbA1c
研究概览
简要总结
The purpose of this study is to determine in type 2 diabetic patients in secondary failure to combined oral therapy whether, besides improvement in glycemic control, addition of exenatide, a new drug introduced to treat diabetes before addition of insulin to current therapy, over 6 months is associated with improvement in beta-cell function, insulin sensitivity following 24-hours discontinuation of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes subjects
- •40 to 80 years
- •body mass index (BMI) between 25 and 40 kg/m²
- •baseline glycated haemoglobin (HbA1c) > 7.0 %, despite a maximally-tolerated combined oral therapy with a BCF stimulant (sulfonylurea or repaglinide) plus metformin
排除标准
- •previous or current use of glitazone
- •previous use of systemic glucocorticoids, weight-reducing drug(s) such as sibutramine
- •previous exposure to GLP-1 receptor agonist or DPP-4 inhibitors
结局指标
主要结局
Improvement in HbA1c
时间窗: 6 months
次要结局
- Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity(6 months)
研究者
研究点 (2)
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