DLBS1449 in Diabetic Patients With Low HDL
2016年8月3日 更新者：Dexa Medica Group
The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo
This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449 in elevating high density lipoprotein (HDL) cholesterol in diabetic patients.
The hypothesis of interest for the study is: the administration of DLBS1449 will elevate HDL-cholesterol level from baseline to the end of study significantly higher than the elevation resulted by placebo.
In addition, the administration of DLBS1449 at the dose of 150 mg daily will provide a significantly better response than that of the lower dose (DLBS1449 75 mg daily).
研究概览
地位
撤销
干预/治疗
详细说明
There will be three groups of treatment by dosage regimen in this study.
Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1449 at a dose of 1 x 75 mg daily, or 2) DLBS1449 at a dose of 1 x 150 mg (two capsules of DLBS1449 75 mg) daily; or 3) placebo, once daily.
Study medication should be administered once daily, in the evening with meal, for eight weeks.
Clinical and laboratory examinations to evaluate investigational drug's efficacy and safety will be performed at baseline and at interval of four weeks over 8-week course of therapy.
研究类型
介入性
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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East Java
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Surabaya、East Java、印度尼西亚
- Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female 21 - 70 years.
- Have been diagnosed diabetes mellitus and being treated with lifestyle intervention for at least 1 month prior to screening, with or without antidiabetic agents.
- HDL-cholesterol level of < 35 mg/dL.
- Triglycerides level of < 200 mg/dL.
- Adequate liver and renal function.
- Statin and/or fenofibrate therapy should have been being regularly taken for >=3 months at stable dose (ONLY for subjects currently under statin and/or fenofibrate therapy).
- Able to take oral medication.
Exclusion Criteria:
- Pregnant or breast-feeding women or willing to be pregnant.
- Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg).
- Any other disease state, including chronic/acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.
- Concurrent treatment with systemic corticosteroids or herbal (alternative) medicines.
- Known allergic or hypersensitive to drugs contain similar active substance with the study medication.
- Participation in any other clinical studies within 30 days prior to screening.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：DLBS1449, 1x75 mg
DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period.
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Study treatment will be DLBS1449 softcapsules at a dose of 1x75 mg daily or DLBS1449 at a dose of 1x150 mg daily.
DLBS1449 will be given every day for 8 weeks.
其他名称：
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实验性的：DLBS1449, 1x150 mg
DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period
|
Study treatment will be DLBS1449 softcapsules at a dose of 1x75 mg daily or DLBS1449 at a dose of 1x150 mg daily.
DLBS1449 will be given every day for 8 weeks.
其他名称：
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安慰剂比较：Placebo
Placebo once daily, taken every day along the study period
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Placebo will be given every day for 8 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Percent change in HDL-cholesterol level
大体时间：8 weeks
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent change in HDL-cholesterol level
大体时间：4 and 8 weeks
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4 and 8 weeks
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Percent change in LDL-cholesterol level
大体时间：4 and 8 weeks
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4 and 8 weeks
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Percent change in sd LDL-cholesterol level
大体时间：4 and 8 weeks
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4 and 8 weeks
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Percent change in triglycerides level
大体时间：4 and 8 weeks
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4 and 8 weeks
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Percent change in total cholesterol level
大体时间：4 and 8 weeks
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4 and 8 weeks
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Change in Apo-A1
大体时间：4 and 8 weeks
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4 and 8 weeks
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Change in Apo-B
大体时间：4 and 8 weeks
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4 and 8 weeks
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Response rate
大体时间：8 weeks
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Response rate is defined as percentage of subjects with HDL-cholesterol >= 40 mg/dL after 8 weeks of treatment.
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8 weeks
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Change in A1c level
大体时间：8 weeks
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8 weeks
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Vital signs
大体时间：4 and 8 weeks
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Vital signs measurements include: blood pressure, heart rate, and respiratory rate.
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4 and 8 weeks
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Routine hematology
大体时间：4 and 8 weeks
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Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
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4 and 8 weeks
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Liver function
大体时间：4 and 8 weeks
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Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase.
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4 and 8 weeks
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Renal function
大体时间：4 and 8 weeks
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Renal function measurement includes: serum creatinine.
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4 and 8 weeks
|
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Electrocardiography (ECG)
大体时间：8 weeks
|
The interpretation of ECG result will be recorded.
Any worsened changes from baseline condition will be counted as adverse events.
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8 weeks
|
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Adverse event
大体时间：1-8 weeks
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Adverse event will be observed and recorded during the study period.
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1-8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD、Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年7月1日
初级完成 (预期的)
2017年10月1日
研究完成 (预期的)
2018年1月1日
研究注册日期
首次提交
2013年10月24日
首先提交符合 QC 标准的
2013年10月24日
首次发布 (估计)
2013年10月30日
研究记录更新
最后更新发布 (估计)
2016年8月4日
上次提交的符合 QC 标准的更新
2016年8月3日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.