NCT02173457已完成3 期
Phase III Study of Chiglitazar in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control Despite Diet and Exercise -- A Multicenter, Randomized, Double-Blind, and Sitagliptin-Controlled Trial
Chipscreen Biosciences, Ltd.37 个研究点 分布在 1 个国家目标入组 740 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 740
- 试验地点
- 37
- 主要终点
- Change in HbA1c from baseline after 24 weeks of treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.
详细描述
The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment of 24 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published on 1999);
- •HbA1c≥ 7.5% and ≤ 10.0% after control of diet and exercises;
- •Male and female,age between 18 and 70 years;
- •BMI between 18.5-35kg/m2;
- •Willing to be assigned to any treatment arm and sign inform consent.
排除标准
- •Type 1 diabetes;
- •Treated by oral or injective antidiabetic drug before screening, including insulin and herb;
- •Fasting plasma glucose > 13.3 mmol/L (240 mg/dL);
- •Resistant hypertension [blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least different classes of drugs];
- •Plasma triglyceride > 500 mg/dL (5.65 mmol/L);
- •Is treating by fibrates;
- •History of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy;
- •Had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months;
- •History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery;
- •Had or is having pancreatic diseases;
- •Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;
- •Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase > 2.5 fold of the upper limit of the normal range;
- •Kidney diseases or serum creatinine exceed the normal range: male > 133 μmol/L or female >108 μmol/L;
- •Had malignancy in the past 5 years, not including basal cell carcinoma;
- •Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers;
- •Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;
- •Edema with unknown reason;
- •Alcohol or drug addiction;
- •Had participated other drugs' clinical trials in the 3 months before screening;
- •Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;
- •Any condition that make investigator consider the subject is not suitable to participate the trial.
研究组 & 干预措施
Arm 1
Experimental
Patients administrate Chiglitazar 32mg once daily for 24 weeks
干预措施: Chiglitazar (Drug)
Arm 2
Experimental
Patients administrate Chiglitazar 48mg once daily for 24 weeks
干预措施: Chiglitazar (Drug)
Arm 3
Active Comparator
Patients administrate Sitagliptin 100mg once daily for 24 weeks
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Change in HbA1c from baseline after 24 weeks of treatment
时间窗: 24 weeks
The change of HbA1c at week 24 from baseline
次要结局
- Change in fasting plasma insulin from baseline(12 and 24 weeks)
- Percentage of patients who discontinue the trial due to hyperglycemia(24 weeks)
- Percentage of patients that attained target HbA1c <7.0%(24 weeks)
- Change in free fatty acid (FFA) from baseline(12 and 24 weeks)
- Change in HbA1c from baseline for patients with a baseline HbA1c <8.5%(24 weeks)
- Change in HbA1c from baseline(12 weeks)
- Percentage of patients whose HbA1c lowered by at least 0.5%(24 weeks)
- Change in 2-h postprandial glucose (2hPPG) from baseline(12 and 24 weeks)
- Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%(24 weeks)
- Change in fasting plasma glucose from baseline(12 and 24 weeks)
- Change in high density lipoprotein cholesterol (HDL-C) from baseline(12 and 24 weeks)
- Change in low density proprotein cholesterol (LDL-C) from baseline(12 and 24 weeks)
- Change in total cholesterol (TC) from baseline(12 and 24 weeks)
- Change in triglyceride from baseline(12 and 24 weeks)
- Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12 and 24 weeks, compared with that of baseline(12 and 24 weeks)
- Change in blood pressure from baseline(24 weeks)
研究者
研究点 (37)
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