NCT02366351Unknown1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Clinical Trial to Evaluate the Pharmacokinetics/Pharmacodynamics, Efficacy and Safety of SHR3824 as Monotherapy in Chinese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change in HbA1c Levels
研究概览
简要总结
The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824 over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a diagnosis of type 2 diabetes mellitus;
- •Hemoglobin A1c levels >=7.5% and <=10.5%;
- •Body mass index (BMI) 25 to 45 kg/m2;
- •Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.
排除标准
- •Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
- •Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
- •Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
- •History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
- •Past or current history of malignant tumor;
- •Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
- •Pregnant women, lactating mothers, or women of childbearing potential;
- •Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
研究组 & 干预措施
SHR3824 Placebo
Experimental
once daily, 12 weeks
干预措施: Placebo (Drug)
SHR3824 5 mg
Experimental
once daily, 12 weeks
干预措施: SHR3824 (Drug)
SHR3824 10 mg
Experimental
once daily, 12 weeks
干预措施: SHR3824 (Drug)
SHR3824 20 mg
Experimental
once daily, 12 weeks
干预措施: SHR3824 (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c Levels
时间窗: Baseline to Week 12
The number of volunteers with adverse events as a measure of safety and tolerability
时间窗: Baseline to Week 12
次要结局
- Adjusted Mean Change in Fasting Plasma Glucose(Baseline to Week 12)
- Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%(Baseline to Week 12)
研究者
研究点 (1)
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