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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLBS1449, 1x75 mg | Experimental | DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period. |
|
| DLBS1449, 1x150 mg | Experimental | DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period |
|
| Placebo | Placebo Comparator | Placebo once daily, taken every day along the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLBS1449 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in HDL-cholesterol level | 8 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD | Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor | Surabaya | East Java | Indonesia |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo | Other | Placebo will be given every day for 8 weeks. |
|
| 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 |