An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 155
- 试验地点
- 3
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit
研究概览
简要总结
This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes
- •Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination
- •BMI 25-45 kg/m^2
- •HbA1c between 7.5 % and 12.0 %, inclusive
排除标准
- •Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening
- •Patients previously treated with AC2993
- •Patients presently treated with insulin
研究组 & 干预措施
AC2993
5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period
干预措施: AC2993 (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit
时间窗: Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Change in HbA1c from Baseline to Week 24, Week 52, and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit
时间窗: Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Visit 10 (Week 24), to Visit 14 (Week 52) and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
次要结局
未报告次要终点