NCT04807348已完成3 期
A Randomised Double-blind Placebo Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Chiglitazar Added to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy (RECAM)
Chipscreen Biosciences, Ltd.50 个研究点 分布在 1 个国家目标入组 533 人开始时间: 2021年7月6日最近更新:
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
- 533
- 试验地点
- 50
- 主要终点
- percentage of HbA1c change from baseline
研究概览
简要总结
The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.
详细描述
This clinical trial is a multi-center, randomized, double-blind, placebo parallel control design, and uses superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
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
- •) Provide a signed and dated informed consent form;
- •) Men and women aged ≥ 18 years and ≤ 75 years;
- •) According to the World Health Organization ( the WHO ) 1999 criteria for the diagnosis of type 2 diabetes;
- •) After metformin stable dose monotherapy (≥1500 mg/day or maximum tolerated dose, but the maximum tolerated dose not < l000 mg/day) for at least 8 weeks;
- •) The local HbA1c value during the screening period: 7.5% ≤ HbA1c ≤ 11% ;
- •) The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c ≤ 10.5% ;
- •) BMI ≥ 18.5 kg/m2 and ≤ 35 kg/m 2 ;
- •) Fasting C- peptide ≥ 0.5 nmol/L ;
- •) Women of Childbearing Potential ( WOCBP ) should take reliable contraceptive measures at least 1 month before the screening, during the entire trial, and within 3 months after completing the trial; male subjects should take reliable contraceptive measures to avoid making their sexual partners to pregnant during the entire trial and within 3 months after the trial.
排除标准
- •) Type 1 diabetes;
- •) Pregnancy or lactation;
- •) The New York Heart Association (NYHA ) defines congestive heart failure as grade III or IV ;
- •) Significant history of cardiovascular and cerebrovascular diseases within 6 months before screening, defined as myocardial infarction, coronary artery bypass graft or angioplasty, valvular disease or repair, unstable angina, transient brain Ischemic attack, or cerebrovascular accident;
- •) Suffered from malignant tumors (except cured basal cell carcinoma) within 5 years before screening;
- •) Edema of lower limbs or edema of the whole body;
- •) Moderate to severe renal insufficiency [ Calculated eGFR<60 ml/ ( min*1.73m2 ) using CKD - EPI formula ];
- •) urinary albumin-to-creatinine ratio of > 300 mg /g;
- •) Triglyceride> 5.6 mmol /L;
- •) Active liver disease and /or obvious liver function abnormalities, defined as AST>2.5 times the upper limit of normal value and/or ALT>2.5 times the upper limit of normal value and/or total bilirubin >1.5 times the normal value Upper limit
- •) Clinically significant arrhythmias in the electrocardiogram examination and treatment or intervention are required. The investigator judges that it is not suitable to participate in this clinical trial;
- •) Human immunodeficiency virus (HIV) antibody-positive; Treponema pallidum antibody positive; positive hepatitis B surface antigen and HBV DNA quantification values were higher than the upper; HCV antibodies and HCV RNA quantification values were higher than the upper ;
- •) History of illegal drug abuse within 12 months before screening ;
- •) Participated in other clinical trials within 90 days before screening ;
- •) Donated whole blood, plasma, or platelets within 3 months before screening.
- •) Before randomization, the investigator judged that the subjects had poor compliance with the study protocol or drug treatment, defined as the subjects taking less than 80% or more than 120% of the prescribed dose of chiglitazar/ placebo or metformin;
- •) The investigator judged that it is not suitable to participate in this clinical trial.
研究组 & 干预措施
Chiglitazar sodium 32mg QD+metformin
Experimental
Chiglitazar 32mg qd+metformin
干预措施: Chiglitazar 32mg (Drug)
Chiglitazar sodium 32mg QD+metformin
Experimental
Chiglitazar 32mg qd+metformin
干预措施: Metformin Hydrochloride (Drug)
Chiglitazar sodium 48 mg QD+metformin
Experimental
Chiglitazar 48 mg qd+metformin
干预措施: Chiglitazar 48mg (Drug)
Chiglitazar sodium 48 mg QD+metformin
Experimental
Chiglitazar 48 mg qd+metformin
干预措施: Metformin Hydrochloride (Drug)
placebo+metformin
Placebo Comparator
placebo+metformin
干预措施: Placebo (Drug)
placebo+metformin
Placebo Comparator
placebo+metformin
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
percentage of HbA1c change from baseline
时间窗: 24 weeks
central lab test
次要结局
- Changes of HOMA-the IR value from baseline(12 and 24 weeks)
- Changes in blood fasting plasma glucose level from baseline(12 and 24 weeks)
- percentage of AEs(28 weeks)
- number of participants with lab abnormality(24 weeks)
- Changes of blood lipids level from baseline(12 and 24 weeks)
研究者
研究点 (50)
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