NCT04141241已完成2 期
Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-week, Therapeutic Exploratory, Phase 2a Study to Evaluate the Safety and Efficacy of PH100 Tablet in T2DM Patients With Recent Cardiovascular Complications
Bota Bio Co., Ltd.0 个研究点目标入组 82 人开始时间: 2016年3月4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
- 82
- 主要终点
- hs-CRP (high-sensitivity C-reactive protein)
研究概览
简要总结
This is a Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-Week, Therapeutic exploratory, Phase IIa Study which will patients with type 2 diabetes mellitus and recent cardiovascular complications.
详细描述
After a screening, 114 patients will be stratified randomized in a 1:1:1 ratio to the 3 arms (PH100 800mg/day, PH100 1600mg/day, Placebo) to evaluate the safety and efficacy of PH100.
Subjects will visit the centers on Week 4, 8 and 12 during the entire 12-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 19 years old
- •Subjects who have been treated for cardiovascular complications (stent insertion due to angina pectoris, myocardial infarction, cerebral ischemia, peripheral vascular disease) within 4 weeks prior to baseline
- •T2DM patients who diagnosed with type 2 diabetes prior to or above cardiovascular complications and have been taking oral hypoglycemic agents and/or receiving insulin treatment before the above complication occurred
- •Subjects taking a stable dose of statins and are anticipated to have no change in dose during the duration of the study
- •The following is confirmed through screening:
- •AST/ALT ≤ 2.5 X ULN
- •Creatinine ≤ 1.5 X ULN
- •Hemoglobin ≥ 10 g/dL
- •6.5% ≤ HbA1c ≤ 11%
- •Women of child-bearing potential who have negative pregnancy testing results and have agreed to use appropriate measures of contraception* during the duration of the study (*appropriate contraception is defined as women of child-bearing potential, excluding women in whom more than 52 weeks have passed since their last period, using the following methods: surgical sterilization, intrauterine device, condoms, barrier contraceptives, absolute abstinence)
- •Subjects who have signed the informed consent form (or whose legal representative has signed) and who are deemed to be able to follow the requirements of the study
排除标准
- •T2DM patients, secondary DM patients, Gestational DM patients
- •Subjects who have a history of secondary hypertension or have a disease history of suspicious secondary hypertension. This includes but is not restricted to: aortic coarctation, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
- •Subjects taking anti-inflammatory agents including corticosteroids/NSAIDs (However, maximum 100mg of aspirin per day is allowed)
- •Subjects with chronic liver/renal disease or malignancy
- •Supplements containing kajime or kajime derivatives (e.g. Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Eckonia Cava, Seanol, Seanol-F, Seanol-EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, Marine D3, Botabio everyone, Botabio power, Botabio red, Botabio premium, Botabio Eplus) and related medications, or subjects who have a history of hypersensitivity to high iodine containing products (seaweed, shellfish, etc.)
- •Pregnant, breast-feeding subjects or subjects who have plans for pregnancy
- •Subjects who have taken supplements containing kajime or kajime derivatives within 4 weeks of baseline (e.g., Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Eckonia Cava, Seanol, Seanol-F, Seanol- EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, Marine D3, Botabio everyone, Botabio power, Botabio red, Botabio premium, Botabio Eplus)
- •Subjects who have participated in another clinical trial within 4 weeks of baseline and have taken other clinical trial medications
- •Subjects who have received treatment for or who test positive for HBsAg, HCV antibody, or HIV at baseline
- •Subjects who have an acute inflammatory disease other than cardiovascular complications within 4 weeks of baseline
- •Subjects who have gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of drugs (e.g. Crohn's disease) and subjects who have a history of gastrointestinal surgery (with the exception of appendectomy and hernia repair), or subjects with active gastritis, gastrointestinal/rectal bleeding, active inflammatory bowel disease within the past 12 months
- •Subjects with autoimmune disease (e.g. rheumatoid arthritis) or who require chronic anti-inflammatory treatment
- •Subjects with a history of drug or alcohol abuse
- •Subjects who are judged not to be appropriate for participation in the study or who have a medical condition that may have an influence on the study results
研究组 & 干预措施
Low Dose PH100: 800mg/day
Experimental
- PH100 (Ecklonia cava Phlorotannin) 200mg/tablet
- PH100 2 tablets (400mg) and Placebo 2 tablets BID during 12wks
干预措施: Ecklonia cava Phlorotannin (Drug)
High Dose PH100: 1600mg/day
Experimental
- PH100 4 tablets (800mg) BID during 12wks
干预措施: Ecklonia cava Phlorotannin (Drug)
Placebo
Placebo Comparator
- Placebo 200mg/tablet
- Placebo 4 tablets BID during 12wks
干预措施: Ecklonia cava Phlorotannin (Drug)
结局指标
主要结局
hs-CRP (high-sensitivity C-reactive protein)
时间窗: Visit 2(Baseline Visit) vs Visit 5(week 12)
Change in hs-CRP level compared to baseline after 12 weeks of investigational product administration
次要结局
- hs-CRP: monthly rate of change(Between Visit 2(Baseline Visit) and Visit 3(week 4), Between Visit 3(week 4) and Visit 4(week 8), Between Visit 4(week 8) and Visit 5(week 12))
- Triglyceride (TG)(Visit 2(Baseline Visit), Visit 5(week 12))
- AE (Adverse Events)(Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
- Pulse(Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
- Interleukin-6 (IL-6)(Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
- MACE (Major Adverse Cardiovascular Events)(Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
- Blood Pressure (Systolic Blood Pressure, Diastolic Blood Pressure)(Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
- Adiponectin(Visit 2(Baseline Visit), Visit 5(week 12))
- Free Fatty Acid(Visit 2(Baseline Visit), Visit 5(week 12))
- Low Density Lipoprotein-cholesterol (LDL-C)(Visit 2(Baseline Visit), Visit 5(week 12))
- hs-CRP(Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8))
- Oxidized Low Density Lipoprotein (Oxidized LDL)(Visit 2(Baseline Visit), Visit 5(week 12))
- Total AntiOxidants (TAS)(Visit 2(Baseline Visit), Visit 5(week 12))
- Total Cholesterol (TC)(Visit 2(Baseline Visit), Visit 5(week 12))
- BMI(Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
- Waist-hip ratio(Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
- Tumor Necrosis Factor-α (TNF- α)(Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
- Malondialdehyde (MDA)(Visit 2(Baseline Visit), Visit 5(week 12))
- Glutathione Peroxidase (GPX)(Visit 2(Baseline Visit), Visit 5(week 12))
- Superoxide Dismutase (SOD)(Visit 2(Baseline Visit), Visit 5(week 12))
- HbA1c(Visit1(screening), Visit 5(week 12))
- High Density Lipoprotein-cholesterol (HDL-C)(Visit 2(Baseline Visit), Visit 5(week 12))
- Homocysteine(Visit 2(Baseline Visit), Visit 5(week 12))
- Fibrinogen(Visit 2(Baseline Visit), Visit 5(week 12))
- Left Ventricular Ejection Fraction(Visit 2(Baseline Visit), Visit 5(week 12))
- Body Temperature(Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12))
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