NCT02767596终止4 期
A Pilot Single-Arm Open-Label Study to Evaluate the Efficacy of Treatment With Lixisenatide in Diabetes Mellitus Type 2 Patients With Failure of Other GLP-1 Analog
Laniado Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年7月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in hemoglobin A1c
研究概览
简要总结
The study aims to examine the effectiveness of the short acting GLP-1 analog, Lixisenatide to achieve glycemic control in type 2 diabetes patients, in patients with failure of long acting GLP-1 analog.
Patients who fail to achieve significant improvement in diabetes control on basal insulin and Liraglutide will be switched to basal insulin and lixisenatide treatment for 12 weeks. The primary outcomes will be changes in HBA1C and weight.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type Diabetes Mellitus on combination of basal insulin therapy and GLP1 analog, with secondary failure of non-fasting glycemic control
排除标准
- •Pregnant or lactating woman
- •Renal failure (eGFR<30)
研究组 & 干预措施
Lixisenatide
Experimental
S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks
干预措施: Lixisenatide (Drug)
Lixisenatide
Experimental
S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks
干预措施: Basal insulins (Drug)
结局指标
主要结局
Change in hemoglobin A1c
时间窗: 16 weeks
Change in body weight
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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