An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Incidence of Potentially Immune-related Treatment-emergent Adverse Events
研究概览
简要总结
The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes.
- •Have been exposed to exenatide for at least 3 months in previous Amylin/Lilly Studies H8O-MC-GWAO, H8O-MC-GWAP, H8O-MC-GWAT, or H8O-MC-GWBA.
- •Have interrupted exenatide treatment for a period of at least 2 months.
- •HbA1c of ≤10.5%.
排除标准
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Have previously completed or withdrawn from this study.
- •Have taken marketed exenatide (Byetta) during the interim period between studies GWAO, GWAP, GWAT, or GWBA and the current study.
- •Used drugs for weight loss (for example, Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], Accomplia® [rimonabant], or similar over-the-counter medications) within 3 months of screening.
- •Are currently treated with any of the following excluded medications: Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
- •Use insulin with daily dosage exceeding 1 U/kg.
研究组 & 干预措施
Exenatide:Treatment-Emergent Antibody Positive
This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.
干预措施: exenatide (Drug)
Exenatide:Treatment-Emergent Antibody Negative
This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.
干预措施: exenatide (Drug)
结局指标
主要结局
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
时间窗: 24 weeks
Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study
Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
时间窗: 24 weeks
Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)
次要结局
- Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint(24 weeks)