NCT04124484已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2017年10月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- HBA1c
研究概览
简要总结
This study evaluate DRBP108 in the treatment of type 2 diabetes mellitus. The patients were randomly allocated to four groups: 50 mg, 100 mg, 200 mg and placebo group.
详细描述
This study was to evaluate DRBP108 in the treatment of type 2 diabetes mellitus. A total of 268 subjects were randomly allocated to four treatment arms: 50 mg, 100 mg, 200 mg or placebo group, in a 1:1:1:1 ratio.
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
- •Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
- •18 ≤ age ≤ 75 years old, male or female;
- •One of the following conditions:
- •Initial diagnosis of type 2 diabetes mellitus;
- •Patients who with type 2 diabetes diagnosed within 2 years before screening period and are treated with single-agent oral hypoglycemic agents until screening, and do not take the medicine regularly for at least 8 weeks (i.e., continuous medication for <1 week);
- •19kg/m^2 ≤ Body Mass Index（BMI ）≤ 35kg/m^2;
- •7.0% ≤ HbA1c ≤ 10.0%;
- •Female subjects of childbearing age are negative in pregnancy test;
- •All the subjects do not have a fertility plan during and three month after the trial;
- •Subjects who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
排除标准
- •FPG > 15 mmol/L;
- •Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg during screening period;
- •Those who are known to be positive for HIV and syphilis;
- •known active hepatitis B virus infection, hepatitis C virus infection;
- •For patients with obvious liver diseases and chronic liver diseases, AST or ALT in screening stage was twice the normal upper limit.
- •In patients with renal insufficiency, serum creatinine at screening stage was 1.5 times higher than the upper limit of normal value;
- •Leukocyte and hemoglobin < lower limit of normal value, triglyceride > 5.7 mmol/L in screening stage;
- •With diabetic acute complications (including diabetic ketoacidosis, hypertonic non-ketoacid diabetic coma, lactic acidosis and hypoglycemic coma), chronic complications (proliferative diabetic retinopathy, diabetic nephropathy);
- •Use of insulin, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist or any combination of two or more oral hypoglycemic drugs within 8 weeks before screening time.
- •Those who need insulin therapy;
- •Using and Used of glucocorticoids within 2 weeks before screening time.
- •without a pacemaker, the 12-lead ECG showed II or III degree atrioventricular block, long QT syndrome or corrected QT interval （QTc）>500ms or atrial fibrillation during the screening period;
- •History of epilepsy, mental illness, major depression, or previous thyroid function abnormal and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease;
- •Inflammatory bowel disease, colon ulcer, partial intestinal obstruction or chronic intestinal diseases associated with digestive and absorption diseases;
- •Active pancreatitis, cholecystitis, gallstones and other digestive diseases;
- •History of severe hypoglycemia;
- •History of allergies with similar drugs (DPP-4 inhibitors) or those who are judged by the investigator to be allergic to the test drug;
- •Pregnancy, lactating women;
- •Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening;
- •Not suitable for this clinical trial judged by the investigator.
研究组 & 干预措施
50mg group
Experimental
Participants received one 50mg of DBPR108 tablet and two placebos matching DBPR108 100mg under fasted conditions for one day.
干预措施: DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg) (Drug)
100mg group
Experimental
Participants received one 100mg of DBPR108 tablet and two placebos matching DBPR108 50mg and 100mg under fasted conditions for one day.
干预措施: DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg) (Drug)
200mg group
Experimental
Participants received two 100mg of DBPR108 tablets and one placebo matching DBPR108 50mg under fasted conditions for one day.
干预措施: DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg) (Drug)
placebo group
Placebo Comparator
Participants received two placebo matching DBPR108 100mg and one placebo matching DBPR108 50mg
干预措施: Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg) (Drug)
结局指标
主要结局
HBA1c
时间窗: Baseline, week 12
Changes in HbA1c compared to baseline at week 12
次要结局
- 2-hour postprandial plasma glucose(Baseline, week 4，week 8, week 12)
- active Glucagon-like peptide-1（GLP-1）(Baseline, week 4，week 8, week 12)
- The percentage of HbA1c≤6.5% or HbA1c≤7%(week 12)
- HBA1c(Baseline, week 8, week4)
- body weight(Baseline, week 4，week 8, week 12)
- fasting glucagon(Baseline, week 4，week 8, week 12)
- Fasting plasma glucose(Baseline, week 4，week 8, week 12)
- fasting Insulin(Baseline, week 4，week 8, week 12)
研究者
研究点 (1)
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