A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 336
- 试验地点
- 127
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)
研究概览
简要总结
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (metformin) throughout 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Type 2 diabetes mellitus
- •Treated with metformin within a defined dose range for at least 3 months prior to screening
- •BMI= 27-45 kg/m2
- •HbA1c value between 7.5% and 11%
排除标准
- •Treated with oral anti-diabetic medications other than metformin within 3 months of screening
- •Patients treated previously with AC2993
- •Patients presently treated with insulin
研究组 & 干预措施
AC2993 5 mcg (0.02 mL)
Placebo, then AC2993 5 mcg, then AC2993 5 mcg
干预措施: AC2993 (Drug)
AC2993 10mcg (0.04 mL)
Placebo, then AC2993 5 mcg, then AC2993 10 mcg
干预措施: AC2993 (Drug)
Placebo 0.02 mL
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
干预措施: Placebo (Drug)
Placebo 0.04 mL
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)
时间窗: Baseline (Day 1), Week 30
Change in HbA1c from from baseline, measured from Visit 3 (Day 1) to study termination (Week 30).
次要结局
- The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more(Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30)
- Change in body weight from Baseline to each intermediate visit and Week 30(Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30)
- Change in HbA1c from baseline (Day 1) to each of the intermediate visits(Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24)
- The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30(Baseline (Day 1) and Week 30)
- The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30(Baseline (Day 1), and Week 30)
- The time to achieve specific HbA1c target values of < 7% and < 8%(Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30)