The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Percent change in HDL-cholesterol level
研究概览
简要总结
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).
详细描述
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
DLBS1449, 1x75 mg
DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period.
干预措施: DLBS1449 (Drug)
DLBS1449, 1x150 mg
DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period
干预措施: DLBS1449 (Drug)
Placebo
Placebo once daily, taken every day along the study period
干预措施: Placebo (Other)
结局指标
主要结局
Percent change in HDL-cholesterol level
时间窗: 8 weeks
次要结局
- Renal function(4 and 8 weeks)
- Change in Apo-B(4 and 8 weeks)
- Liver function(4 and 8 weeks)
- Change in A1c level(8 weeks)
- Vital signs(4 and 8 weeks)
- Electrocardiography (ECG)(8 weeks)
- Percent change in HDL-cholesterol level(4 and 8 weeks)
- Percent change in sd LDL-cholesterol level(4 and 8 weeks)
- Percent change in triglycerides level(4 and 8 weeks)
- Percent change in total cholesterol level(4 and 8 weeks)
- Percent change in LDL-cholesterol level(4 and 8 weeks)
- Change in Apo-A1(4 and 8 weeks)
- Response rate(8 weeks)
- Routine hematology(4 and 8 weeks)
- Adverse event(1-8 weeks)