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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor
Surabaya, East Java, Indonesia
Percent change in HDL-cholesterol level
Time frame: 8 weeks
Percent change in HDL-cholesterol level
Time frame: 4 and 8 weeks
Percent change in LDL-cholesterol level
Time frame: 4 and 8 weeks
Percent change in sd LDL-cholesterol level
Time frame: 4 and 8 weeks
Percent change in triglycerides level
Time frame: 4 and 8 weeks
Percent change in total cholesterol level
Time frame: 4 and 8 weeks
Change in Apo-A1
Time frame: 4 and 8 weeks
Change in Apo-B
Time frame: 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.
Time frame: 8 weeks
Change in A1c level
Time frame: 8 weeks
Vital signs
Vital signs measurements include: blood pressure, heart rate, and respiratory rate.
Time frame: 4 and 8 weeks
Routine hematology
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Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
Time frame: 4 and 8 weeks
Liver function
Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase.
Time frame: 4 and 8 weeks
Renal function
Renal function measurement includes: serum creatinine.
Time frame: 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.
Time frame: 8 weeks
Adverse event
Adverse event will be observed and recorded during the study period.
Time frame: 1-8 weeks