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DLBS1449 in Diabetic Patients With Low HDL

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ClinicalTrials.gov Identifier: NCT01972477
Recruitment Status : Withdrawn
First Posted : October 30, 2013
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diabetic Patients Low HDL-cholesterol (< 35 mg/dL) Lifestyle Intervention for at Least 1 Month Drug: DLBS1449 Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo
Study Start Date : July 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Percent change in HDL-cholesterol level [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Percent change in HDL-cholesterol level [ Time Frame: 4 and 8 weeks ]
  2. Percent change in LDL-cholesterol level [ Time Frame: 4 and 8 weeks ]
  3. Percent change in sd LDL-cholesterol level [ Time Frame: 4 and 8 weeks ]
  4. Percent change in triglycerides level [ Time Frame: 4 and 8 weeks ]
  5. Percent change in total cholesterol level [ Time Frame: 4 and 8 weeks ]
  6. Change in Apo-A1 [ Time Frame: 4 and 8 weeks ]
  7. Change in Apo-B [ Time Frame: 4 and 8 weeks ]
  8. Response rate [ Time Frame: 8 weeks ]
    Response rate is defined as percentage of subjects with HDL-cholesterol >= 40 mg/dL after 8 weeks of treatment.

  9. Change in A1c level [ Time Frame: 8 weeks ]
  10. Vital signs [ Time Frame: 4 and 8 weeks ]
    Vital signs measurements include: blood pressure, heart rate, and respiratory rate.

  11. Routine hematology [ Time Frame: 4 and 8 weeks ]
    Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.

  12. Liver function [ Time Frame: 4 and 8 weeks ]
    Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase.

  13. Renal function [ Time Frame: 4 and 8 weeks ]
    Renal function measurement includes: serum creatinine.

  14. Electrocardiography (ECG) [ Time Frame: 8 weeks ]
    The interpretation of ECG result will be recorded. Any worsened changes from baseline condition will be counted as adverse events.

  15. Adverse event [ Time Frame: 1-8 weeks ]
    Adverse event will be observed and recorded during the study period.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972477


Locations
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Indonesia
Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor
Surabaya, East Java, Indonesia
Sponsors and Collaborators
Dexa Medica Group
Investigators
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Principal Investigator: Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital

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Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01972477     History of Changes
Other Study ID Numbers: DLBS1449-0111
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Keywords provided by Dexa Medica Group:
DLBS1449
diabetes mellitus
HDL-cholesterol