DLBS1449 in Diabetic Patients With Low HDL

The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo

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).

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Patients; Low HDL-cholesterol (< 35 mg/dL); Lifestyle Intervention for at Least 1 Month
• Intervention / Treatment: Drug: DLBS1449; Other: Placebo

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLBS1449, 1x75 mg; DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period.	Drug: 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.; Other Names: Forhidrol
Experimental: DLBS1449, 1x150 mg; DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period	Drug: 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.; Other Names: Forhidrol
Placebo Comparator: Placebo; Placebo once daily, taken every day along the study period	Other: Placebo; Placebo will be given every day for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in HDL-cholesterol level	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in HDL-cholesterol level		4 and 8 weeks
Percent change in LDL-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
Change in Apo-A1		4 and 8 weeks
Change in Apo-B		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.	8 weeks
Change in A1c level		8 weeks
Vital signs	Vital signs measurements include: blood pressure, heart rate, and respiratory rate.	4 and 8 weeks
Routine hematology	Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.	4 and 8 weeks
Liver function	Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase.	4 and 8 weeks
Renal function	Renal function measurement includes: serum creatinine.	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.	8 weeks
Adverse event	Adverse event will be observed and recorded during the study period.	1-8 weeks

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD, Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (Estimate): October 30, 2013

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: diabetes mellitus; HDL-cholesterol; DLBS1449
• Other Study ID Numbers: DLBS1449-0111