Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.
研究概览
简要总结
This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
- •HbA1c between 7.1% and 11.0%, inclusive.
- •Insulin therapy should be the next appropriate step of diabetes treatment.
- •Body Mass Index (BMI) >25 kg/m2 and <40 kg/m
排除标准
- •Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
- •Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.
研究组 & 干预措施
exenatide/insulin glargine
Arm that first receives exenatide, then crosses over to insulin glargine
干预措施: exenatide/insulin glargine (Drug)
Insulin glargine/exenatide
Arm that first receives insulin glargine, then crosses over to exenatide
干预措施: insulin glargine/exenatide (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.
时间窗: Baseline, Week 16, Week 32
Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.
次要结局
- Change in patient-reported outcomes from Baseline to the end of each 16-week period(Baseline, Week 16, Week 32)