DLBS1449 in Diabetic Patients With Low HDL

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo

Conditions
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Diabetic Patients, Low HDL-cholesterol (< 35 mg/dL), Lifestyle Intervention for at Least 1 Month

Intervention / Treatment
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* Drug: DLBS1449
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DLBS1449, 1x75 mg<br>DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period. | Drug: DLBS1449<br>* 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.<br>* Other names: Forhidrol;|
| Experimental: DLBS1449, 1x150 mg<br>DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period | Drug: DLBS1449<br>* 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.<br>* Other names: Forhidrol;|
| Placebo Comparator: Placebo<br>Placebo once daily, taken every day along the study period | Other: Placebo<br>* Placebo will be given every day for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in HDL-cholesterol level |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in HDL-cholesterol level |  | 4 and 8 weeks | 
| Percent change in LDL-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 | 
| Change in Apo-A1 |  | 4 and 8 weeks | 
| Change in Apo-B |  | 4 and 8 weeks | 
| Response rate | Response rate is defined as percentage of subjects with HDL-cholesterol >= 40 mg/dL after 8 weeks of treatment. | 8 weeks | 
| Change in A1c level |  | 8 weeks | 
| Vital signs | Vital signs measurements include: blood pressure, heart rate, and respiratory rate. | 4 and 8 weeks | 
| Routine hematology | Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count. | 4 and 8 weeks | 
| Liver function | Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase. | 4 and 8 weeks | 
| Renal function | Renal function measurement includes: serum creatinine. | 4 and 8 weeks | 
| Electrocardiography (ECG) | The interpretation of ECG result will be recorded. Any worsened changes from baseline condition will be counted as adverse events. | 8 weeks | 
| Adverse event | Adverse event will be observed and recorded during the study period. | 1-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBS1449, diabetes mellitus, HDL-cholesterol