研究疾病:
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2型糖尿病伴血脂异常
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研究疾病代码:
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Target disease:
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Type 2 Diabetes Mellitus with Dyslipidemia
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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上市后药物
Post-marketing clinical trial
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研究目的:
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1.主要目的:在2型糖尿病伴血脂异常患者中,比较血脂康1.2g/日与普伐他汀20mg/日治疗6周对空腹甘油三酯(TG)水平的影响。
2.次要目的:
(1)评估血脂康与普伐他汀治疗对其他空腹血脂指标水平的影响,包括TC、LDL-C、HDL-C、非HDL-C(nonHDL-C = TC - HDL-C)、残粒胆固醇(RC = TC - HDL-C - LDL-C)、脂蛋白(a)[Lp(a)]、载脂蛋白A1(ApoA1)、载脂蛋白B(ApoB);
(2)评估血脂康与普伐他汀治疗对餐后各时间点TG水平的影响,包括餐后1、2、4小时;
(3)评估血脂康与普伐他汀治疗对空腹及餐后各时间点高敏C反应蛋白(hs-CRP)水平的影响,包括餐后2、4小时;
(4)评估血脂康与普伐他汀治疗对空腹及餐后各时间点血糖水平的影响,包括餐后1、2小时;
(5)评估血脂康与普伐他汀治疗对空腹及餐后各时间点胰岛素水平的影响,包括餐后1、2小时;
(6)评估血脂康与普伐他汀治疗对空腹糖化血红蛋白(HbA1c%)水平的影响;
(7)探索空腹及餐后TG水平的变化与hs-CRP及胰岛素水平的关系。
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Objectives of Study:
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1. Main purpose: to compare the effects of Xuezhikang 1.2g/day and pravastatin 20mg/day on fasting triglyceride (TG) levels in patients with type 2 diabetes mellitus and dyslipidemia.
2. Secondary purpose:
(1) Assess the effect of Xuezhikang and Pravastatin treatment on other fasting blood lipid levels, including TC, LDL-C, HDL-C, non-HDL-C (nonHDL-C = TC-HDL-C), residual cholesterol (RC = TC-HDL-C-LDL-C), lipoprotein (a) [Lp (a)], apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB);
(2) Assess the effects of Xuezhikang and Pravastatin treatment on TG levels at various time points after meals, including 1, 2, and 4 hours after meals;
(3) Assess the effects of Xuezhikang and Pravastatin treatments on the levels of high-sensitivity C-reactive protein (hs-CRP) at various time points after fasting and after meals, including 2 and 4 hours after meals;
(4) Assess the effects of Xuezhikang and Pravastatin treatments on fasting and blood glucose levels at various time points after meals, including 1, 2 hours after meals;
(5) Assess the effects of Xuezhikang and Pravastatin treatment on insulin levels on fasting and at various time points after meals, including 1 and 2 hours after meals;
(6) Assess the effect of Xuezhikang and Pravastatin treatment on fasting hemoglobin glycosylated (HbA1c%) levels;
(7) Explore the relationship between the changes in fasting and postprandial TG levels and hs-CRP and insulin levels.
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药物成份或治疗方案详述:
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1.研究药物
试验药:血脂康胶囊,规格:0.3 g/粒,生产企业:北大维信生物科技有限公司;
对照药:普伐他汀钠片,规格:20mg/粒,生产企业:第一三共制药有限公司。
2.剂量和治疗方案
试验组:血脂康胶囊,每日2次,每次2粒,早晚饭后服用;
对照组:普伐他汀钠片,每日1次,每次20mg,临睡前服用;
均连续性服药6周。
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Description for medicine or protocol of treatment in detail:
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1. Investigational product
Experimental drug: Xuezhikang Capsule, 0.3g/capsule Manufacturer: WBL Peking University Biotech Co.
Control drug: Pravastatin sodium tablets, 20mg/tablet Manufacturer: Daiichi Sankyo Company Limited.
2. Dose and treatment regimens
Experimental group: Xuezhikang Capsule, 1.2 g / day, twice a day, 2 capsules each time, after meals in the morning and evening;
Control group: pravastatin sodium tablets, 20mg/dayonce a day, one tablet each time, before bedtime;
Continuous treatment for 6 weeks.
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纳入标准:
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1.年龄≥18岁。
2.已诊断的2型糖尿病患者,根据2020年美国糖尿病学会(ADA)制定的《糖尿病医学诊疗标准》,需要满足以下任一条标准:
(1)空腹血浆葡萄糖≥7.0mmol/L,空腹状态指至少8h没有热量摄入;
(2)OGTT 2小时血浆葡萄糖≥11.1mmol/L,OGTT方法根据WHO标准,口服无水葡萄糖粉75g;
(3)HbA1c≥6.5%,HbA1c检测采用通过NGSP和DCCT认证的方法;
(4)有高血糖典型症状或高血糖危险的患者,随机血糖≥11.1mmol/L,患者研究期间在内分泌专科医生指导下进行糖尿病治疗。
3.存在以下至少一种情况:
(1)2型糖尿病病史≥10年;
(2)吸烟;
(3)肥胖[BMI≥28Kg/m^2, 或腰围≥90cm(男)或≥85cm(女)];
(4)高血压;
(5)近四周空腹HDL-C<1.0mmol/L 或者 LDL-C ≥2.6mmol/L。
4.近4周内血脂异常需同时符合下列两种情况:
(1)1.7mmol/L≤ 空腹TG<5.6mmol/L;
(2)1.8mmol/L≤ 空腹LDL-C<4.9mmol/L。
5.研究期间,入选的患者愿意接受并遵守饮食宣教。
6.患者必须能够遵守定期的访视、治疗计划和所有实验室检查。
7.签署知情同意,自愿受试。
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Inclusion criteria
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1. Aged >= 18 years.
2. Diagnosed type 2 diabetes patients, according to the "Diabetes Medical Diagnosis and Treatment Standards" established by the American Diabetes Association (ADA) in 2020, need to meet any of the following criteria:
(1) Fasting plasma glucose >= 7.0mmol/L, fasting state means no calorie intake for at least 8 hours;
(2) OGTT 2 hours plasma glucose >= 11.1mmol/L, OGTT method according to WHO standard, oral anhydrous glucose powder 75g;
(3) HbA1c>=6.5%, HbA1c detection adopts NGSP and DCCT certification methods;
(4) Patients with typical symptoms of hyperglycemia or risk of hyperglycemia, random blood glucose >= 11.1mmol/L, and treatment of diabetes under the guidance of an endocrinologist during the study period.
3. At least one of the following conditions exists:
(1) History of type 2 diabetes >=10 years;
(2) Smoking;
(3) Obesity [BMI >= 28Kg/m^2, or waist circumference>=90cm (male) or >= 85cm (female)];
(4) Hypertension;
(5) Fasting HDL-C < 1.0mmol/L or LDL-C >= 2.6mmol/L in the past four weeks.
4. Abnormal blood lipids in the past 4 weeks must meet the following two conditions at the same time:
(1) 1.7mmol/L <= Fasting TG < 5.6mmol/L;
(2) 1.8mmol/L <= fasting LDL-C < 4.9mmol/L.
5. During the study period, the selected patients are willing to accept and comply with dietary education.
6. The patient must be able to comply with regular visits, treatment plans and all laboratory tests.
7. Sign informed consent and take the test voluntarily.
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排除标准:
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1.患有动脉粥样硬化性心血管疾病包括冠状动脉粥样硬化性心脏病、缺血性卒中、短暂性脑缺血发作、外周动脉疾病等的患者;
2.在近三个月内服用过调脂药物的患者;
3.尚未控制好血糖的糖尿病患者,即HbA1c%≥8.0%;
4.活动性肝炎或无法解释的持续的血清氨基转移酶升高或血清氨基转移酶水平大于3倍正常上限;
5.肌病患者或不能用肌肉损伤解释的血清肌酸激酶升高(大于5倍正常上限);
6.对血脂康或普伐他汀成分过敏、长期服用糖皮质激素或避孕药者;
7.处于各种感染性疾病急性期、患有甲状腺功能亢进或减退、急性脑血管病、重度心或肾功能不全(>CKD3期)、恶性肿瘤、造血系统疾病、自身免疫系统疾病、严重影响消化或/和吸收功能的消化系统疾病、精神疾病、严重的或者不稳定的躯体疾病任意一项的患者;
8.既往三个月内有酒精或药物滥用或依赖;
9.近三个月内参加过其它药物的临床试验者;
10.研究者认为存在不适合参加该试验的其他情况。
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Exclusion criteria:
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1. Patients suffering from atherosclerotic cardiovascular diseases, including coronary atherosclerotic heart disease, ischemic stroke, transient ischemic attack, peripheral artery disease, etc.;
2. Patients who have taken lipid-lowering drugs in the past three months;
3. Diabetic patients who have not controlled their blood sugar well, that is, HbA1c%>=8.0%;
4. Active hepatitis or unexplained continuous increase in serum aminotransferase or serum aminotransferase level greater than 3 times the upper limit of normal;
5. Patients with myopathy or increased serum creatine kinase that cannot be explained by muscle damage (greater than 5 times the upper limit of normal);
6. Patients who are allergic to Xuezhikang or pravastatin, and take glucocorticoids or contraceptives for a long time;
7. In the acute stage of various infectious diseases, suffering from hyperthyroidism or hypothyroidism, acute cerebrovascular disease, severe heart or renal insufficiency ( > CKD3 stage), malignant tumor, hematopoietic system disease, autoimmune system disease, severe impact Patients with digestive or/and absorptive digestive diseases, mental diseases, severe or unstable physical diseases;
8. Abuse or dependence on alcohol or drugs in the past three months;
9. Patients who have participated in clinical trials of other drugs in the past three months;
10. The researcher believes that there are other situations that are not suitable for participating in the trial.
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研究实施时间:
Study execute time:
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从From
2021-06-01
至To
2022-08-31
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征募观察对象时间:
Recruiting time:
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从From
2021-06-01
至To
2022-07-20
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