Clinical trial NCT01972477: DLBS1449 in Diabetic Patients With Low HDL
Official title: The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Diabetic Patients
Low HDL-cholesterol (< 35 mg/dL)
Lifestyle Intervention for at Least 1 Month
Keywords: DLBS1449
diabetes mellitus
HDL-cholesterol
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2013-10-30
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent change in HDL-cholesterol level
timeFrame: 8 weeks
Secondary outcomes:
measure: Percent change in HDL-cholesterol level
timeFrame: 4 and 8 weeks
measure: Percent change in LDL-cholesterol level
timeFrame: 4 and 8 weeks
measure: Percent change in sd LDL-cholesterol level
timeFrame: 4 and 8 weeks
measure: Percent change in triglycerides level
timeFrame: 4 and 8 weeks
measure: Percent change in total cholesterol level
timeFrame: 4 and 8 weeks
measure: Change in Apo-A1
timeFrame: 4 and 8 weeks
measure: Change in Apo-B
timeFrame: 4 and 8 weeks
measure: Response rate
timeFrame: 8 weeks
measure: Change in A1c level
timeFrame: 8 weeks
measure: Vital signs
timeFrame: 4 and 8 weeks
measure: Routine hematology
timeFrame: 4 and 8 weeks
measure: Liver function
timeFrame: 4 and 8 weeks
measure: Renal function
timeFrame: 4 and 8 weeks
measure: Electrocardiography (ECG)
timeFrame: 8 weeks
measure: Adverse event
timeFrame: 1-8 weeks
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor
state: East Java
Study officials:
affiliation: Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
name: Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD
role: PRINCIPAL_INVESTIGATOR
References: