A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in 24-hour weighted mean blood glucose
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.
详细描述
The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 20 years at the time of informed consent
- •Japanese patients with type 2 diabetes
- •Patients who have HbA1c ≥ 7.0% and < 10.0% if untreated with antidiabetic agent.
- •Patients who have HbA1c ≥ 6.5% and < 9.5% if treated with antidiabetic agent.
排除标准
- •Patients aged ≥ 70 years at the time of informed consent
- •Patients with a history of type 1 diabetes or diabetic ketoacidosis
- •Patients receiving or requiring treatment with insulin
- •Patients with a body mass index (BMI) of < 18.5 kg/m2 or ≥ 35.0 kg/m2
- •Patients with an estimated glomerular filtration rate (eGFR), < 45 mL/min per 1.73 m2
- •Patients with fasting plasma glucose ≥ 240 mg/dL
研究组 & 干预措施
DS-8500a 10mg once daily
10mg DS-8500a tablet given orally once daily
干预措施: 10mg DS-8500a tablet (Drug)
DS8500a 75 mg once daily
75mg DS-8500a tablet given orally once daily
干预措施: 75mg DS-8500a tablet (Drug)
placebo to match DS-8500a tablet
placebo matching DS-8500a tablet
干预措施: placebo (Drug)
结局指标
主要结局
change in 24-hour weighted mean blood glucose
时间窗: Day -1 (baseline) to Day 28
次要结局
- change in blood fasting plasma glucose level(Day -1 (baseline) to Days 7, 14, 21, 28)
- change in blood insulin level(Day -1 (baseline) to Days 14 and 28)
- change in blood active GLP-1 level(Day -1 (baseline) to Days 14 and 28)
- change in 24 hour weighted mean blood glucose(Day -1 (baseline) to Day 14)
- change in blood plasma glucose level(Day -1 (baseline) to Days 14 and 28)
- change in blood C-peptide level(Day -1 (baseline) to Days 14 and 28)
- change in blood HbA1c level(Day -1 (baseline) to Days 14 and 28)
- change in blood glycoalbumin level(Day -1 (baseline) to Days 14 and 28)
- change in blood PYY level(Day -1 (baseline) to Days 14 and 28)
- Number of subjects experiencing adverse events as a measure of safety(Day -1 (baseline) to Day 28)
- change in postprandial plasma glucose level(Day -1 (baseline) to Days 14 and 28)
- pharmacokinetic profile of DS-8500a(Day -1 (baseline) to Day 28)