A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 156
- 试验地点
- 32
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
研究概览
简要总结
This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 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 with diet and exercise alone or with metformin for at least 3 months prior to screening
- •BMI 27-45 kg/m^2
- •HbA1c between 7.0 % and 8.0 %
排除标准
- •Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
- •Patients previously treated with AC2993
- •Patients presently treated with insulin
研究组 & 干预措施
Placebo 0.01 mL
2 week placebo lead-in followed by Placebo 0.01 mL
干预措施: Placebo 0.01 mL (Drug)
Placebo 0.02 mL
2 week placebo lead-in followed by Placebo 0.02 mL
干预措施: Placebo 0.02 mL (Drug)
Placebo 0.03 mL
2 week placebo lead-in followed by Placebo 0.03 mL
干预措施: Placebo 0.03 mL (Drug)
Placebo 0.04 mL
2 week placebo lead-in followed by Placebo 0.04 mL
干预措施: Placebo 0.04 mL (Drug)
AC2993 2.5 mcg
2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL
干预措施: AC2993 2.5 mcg (Drug)
AC2993 5.0 mcg
2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL
干预措施: AC2993 5.0 mcg (Drug)
AC2993 7.5 mcg
2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL
干预措施: AC2993 7.5 mcg (Drug)
AC2993 10.0 mcg
2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL
干预措施: AC2993 10.0 mcg (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
时间窗: Baseline (Day 1) to Day 28
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
次要结局
- Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28(Baseline, Day 14, Day 28)
- Change in HbA1c from Baseline to Day 14(Baseline, Day 14)
- Change in fasting plasma glucose from Baseline to Day 14 and to Day 28(Baseline, Day 14, Day28)