DLBS1449 in Diabetic Patients With Low HDL
- Conditions
- Lifestyle Intervention for at Least 1 MonthDiabetic PatientsLow HDL-cholesterol (< 35 mg/dL)
- Interventions
- Other: Placebo
- Registration Number
- NCT01972477
- Lead Sponsor
- Dexa Medica Group
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DLBS1449, 1x75 mg DLBS1449 DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period. Placebo Placebo Placebo once daily, taken every day along the study period DLBS1449, 1x150 mg DLBS1449 DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period
- Primary Outcome Measures
Name Time Method Percent change in HDL-cholesterol level 8 weeks
- Secondary Outcome Measures
Name Time Method Change in Apo-B 4 and 8 weeks Liver function 4 and 8 weeks Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase.
Renal function 4 and 8 weeks Renal function measurement includes: serum creatinine.
Change in A1c level 8 weeks Vital signs 4 and 8 weeks Vital signs measurements include: blood pressure, heart rate, and respiratory rate.
Electrocardiography (ECG) 8 weeks The interpretation of ECG result will be recorded. Any worsened changes from baseline condition will be counted as adverse events.
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 Response rate is defined as percentage of subjects with HDL-cholesterol \>= 40 mg/dL after 8 weeks of treatment.
Routine hematology 4 and 8 weeks Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
Adverse event 1-8 weeks Adverse event will be observed and recorded during the study period.
Trial Locations
- Locations (1)
Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor
š®š©Surabaya, East Java, Indonesia