A Phase 2, Prospective, Randomized, Multicenter, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Progression From Prediabetes to Diabetes
研究概览
简要总结
Researchers are trying to determine if an anti-diabetes medication, called Exenatide SR, is well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's effective in preventing diabetes.
详细描述
New diabetes can develop after transplant and may affect a transplanted kidney's health and a recipient's overall health. Currently, patients who are pre-diabetic are encouraged to exercise and lose weight. Researchers are planning to test whether an addition of this medication will lead to better results and more effectively prevent diabetes in patients who already have high blood sugars.
Exenatide SR is medication given by weekly injection. It increases insulin release in response to a meal and slows digestion. This medicine is already in use and approved by the US Food and Drug Administration (FDA) in patients with diabetes. However, it has not been approved for this indication; the FDA has allowed the use of this drug in this research study.
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 —（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
Exenatide SR Intervention Group
Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.
干预措施: Exenatide SR (Drug)
结局指标
主要结局
Progression From Prediabetes to Diabetes
时间窗: 12 months after transplantation
Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation
次要结局
- Graft Loss(From enrollment, up to 20 months post-enrollment)
- Hemoglobin A1c(12 and 24 months after kidney transplantation)
- Incidence of Mesangial Expansion(12 and 24 months after kidney transplantation)
- Progression From Prediabetes to Diabetes(24 months after transplantation)
- Incidence of Death(From enrollment, up to 20 months post-enrollment)
- Creatinine(From enrollment, up to 20 months post-enrollment)
- Adverse Events for Exenatide SR Intervention(12 months)