An Efficacy, Safety, and Tolerability Study of SHR3824 in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
试验速览
- 阶段
- 1 期
- 入组人数
- 168
- 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 evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.
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 been treated with metformin for more than 8 weeks with dose more than 1500mg/day.
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
SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
干预措施: Placebo (Drug)
SHR3824 Placebo
SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
干预措施: Metformin (Drug)
SHR3824 5 mg
SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
干预措施: SHR3824 (Drug)
SHR3824 5 mg
SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
干预措施: Metformin (Drug)
SHR3824 10 mg
SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
干预措施: SHR3824 (Drug)
SHR3824 10 mg
SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
干预措施: Metformin (Drug)
SHR3824 20 mg
SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
干预措施: SHR3824 (Drug)
SHR3824 20 mg
SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
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 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
- Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%(Baseline to Week 12)
- Adjusted Mean Change in Fasting Plasma Glucose(Baseline to Week 12)