Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Plasma glucose concentration of SHR3824
研究概览
简要总结
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in Type 2 diabetes mellitus patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI:20-35kg/m2;
- •Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
- •On a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (FPG) concentration lower than 13.9 mmol/L at baseline;
- •Stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (HbA1c) between 7.0% and 10.0%.
排除标准
- •History of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes.
- •Pregnancy or breastfeeding;
- •Significant acute or chronic medical illness, including renal impairment, or recent surgery;
- •Donation of blood or plasma within the 4 weeks prior to the start of the study;
研究组 & 干预措施
Cohort2
10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
干预措施: Placebo (Drug)
Cohort1
5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
干预措施: SHR3824 (Drug)
Cohort1
5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
干预措施: Placebo (Drug)
Cohort2
10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
干预措施: SHR3824 (Drug)
Cohort3
20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
干预措施: SHR3824 (Drug)
Cohort3
20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma glucose concentration of SHR3824
时间窗: up to Day 11
Urine glucose concentration of SHR3824
时间窗: up to Day 11
Plasma pharmacokinetic parameters of SHR3824
时间窗: up to Day 13
次要结局
- The number and type of adverse events reported(Up to Day 13)