Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 Combined With Metformin in Metformin Monotherapy Poorly Glycemic Controlled Chinese Type 2 Diabetic Patients
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 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese Type 2 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.
详细描述
A phase III clinical study on efficacy and safety of SHR3824 combined with metformin for type 2 diabetes with poor glucose control in metformin monotherapy (multicenter, randomized, double-blind, placebo-parallel control). The 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening.
Evaluation of efficacy: compared with the group of placebo combined with metformin, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the SHR3824 with metformin group
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;
- •Patients with type 2 diabetes mellitus treated with metformin monotherapy for ≥ 8 weeks and poor glycemic control, metformin dose stabilized ≥1500mg / day;
- •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+Metformin, Placebo+Metformin
once daily for SHR3824 and placebo, three times daily for metformin, 24 weeks
干预措施: Placebo (Drug)
SHR3824 5 mg+Metformin
once daily for SHR3824, three times daily for metformin, 52 weeks
干预措施: SHR3824 (Drug)
SHR3824 5 mg+Metformin
once daily for SHR3824, three times daily for metformin, 52 weeks
干预措施: metformin (Drug)
SHR3824 10 mg+Metformin
once daily for SHR3824, three times daily for metformin, 52 weeks
干预措施: SHR3824 (Drug)
SHR3824 10 mg+Metformin
once daily for SHR3824, three times daily for metformin, 52 weeks
干预措施: metformin (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c Levels
时间窗: Baseline to Week 24
Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group
次要结局
- The number of volunteers with adverse events as a measurement of safety(Baseline to Week 52)
- Adjusted Mean Change in Fasting Plasma Glucose(Baseline to Week 24)