DLBS1449 in Diabetic Patients With Low HDL

NCT ID: NCT01972477

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DLBS1449, 1x75 mg

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

Group Type: EXPERIMENTAL

DLBS1449

Intervention Type: 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.

DLBS1449, 1x150 mg

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

Group Type: EXPERIMENTAL

DLBS1449

Intervention Type: 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.

Placebo

Placebo once daily, taken every day along the study period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be given every day for 8 weeks.

Interventions

DLBS1449

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.

Intervention Type: DRUG

Placebo

Placebo will be given every day for 8 weeks.

Intervention Type: OTHER

Other Intervention Names

Forhidrol

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD

Role: PRINCIPAL_INVESTIGATOR

Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital

Locations

Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor

Surabaya, East Java, Indonesia

Countries

Indonesia

Other Identifiers

DLBS1449-0111

Identifier Type: -

Identifier Source: org_study_id