A Phase 2, Randomized, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- First-phase and Second-phase secretion Insulin
研究概览
简要总结
The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（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 < 9.0%
排除标准
- •Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or 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 clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of < 45 mL/min per 1.73 m2) or clinically significant renal disease
- •Patients with fasting plasma glucose ≥ 240 mg/dL
研究组 & 干预措施
Placebo
tablets, orally, once daily for up to 28 days
干预措施: placebo (Drug)
DS-8500a 75 mg once daily (QD)
tablets, orally, once daily for up to 28 days
干预措施: DS-8500a (Drug)
结局指标
主要结局
First-phase and Second-phase secretion Insulin
时间窗: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide
时间窗: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion (C-peptide)
次要结局
- M/I value(Baseline to Day 28 (Period 1 and 2))
- Number and severity of Adverse Events(Day 28 (Period 1 and 2))
- plasma concentration of DS-8500a(Day 28 (Period 1 and 2))
- M value(Baseline to Day 28 (Period 1 and 2))
- Disposition Index(Baseline to Day 28 (Period 1 and 2))