NCT03159052Unknown3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 as Monotherapy in in Chinese Type 2 Diabetic Patients With Inadequate Glycemic Control by Diet and Exercise
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 450
- 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 efficacy and safety of SHR3824 over 24 weeks and 52 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;
- •Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 8 weeks;
- •FPG<=15mmol/L;
- •Hemoglobin A1c levels >=7.0% and <=10.5%;
- •Body mass index (BMI) 19 to 35 kg/m2;
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, 24 weeks
干预措施: Placebo (Drug)
SHR3824 5 mg
Experimental
once daily, 52 weeks
干预措施: SHR3824 (Drug)
SHR3824 10 mg
Experimental
once daily, 52 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 24
The number of volunteers with adverse events as a measure of safety
时间窗: Baseline to Week 52
次要结局
- Adjusted Mean Change in Fasting Plasma Glucose(Baseline to Week 24)
研究者
研究点 (1)
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