An Exploratory Study of the Safety of Substituting Exenatide for Insulin in Patients With Type 2 Diabetes Who Have Been Using Insulin in Combination With Oral Antidiabetic Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16
研究概览
简要总结
This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).
详细描述
This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. All patients will continue their current diet and exercise regimen during the 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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have been treated with insulin for >=3 months up to 12 years.
- •HbA1c <=10.5%.
- •Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.
排除标准
- •Patients previously received exenatide or GLP-1 analogs.
- •Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.
研究组 & 干预措施
Exenatide
The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.
干预措施: exenatide (Drug)
Insulin
The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.
干预措施: Insulin (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16
时间窗: Baseline, Week 16
Change in HbA1c from Baseline study termination (Week 16)
次要结局
未报告次要终点