DLBS1449 in Diabetic Patients With Low HDL

Dexa Medica

Status and phase: Withdrawn; Phase 3; Phase 2

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

Treatments: Other: Placebo; Drug: DLBS1449

Study type: Interventional

Funder types: Industry

Identifiers

NCT01972477

DLBS1449-0111

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

DLBS1449, 1x75 mg

Experimental group

Description:

DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period.

Treatment:

Drug: DLBS1449

DLBS1449, 1x150 mg

Experimental group

Description:

DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period

Treatment:

Drug: DLBS1449

Placebo

Placebo Comparator group

Description:

Placebo once daily, taken every day along the study period

Treatment:

Other: Placebo