NCT01972477

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
2.7 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

October 24, 2013

Last Update Submit

August 3, 2016

Conditions

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

Keywords

DLBS1449diabetes mellitusHDL-cholesterol

Outcome Measures

Primary Outcomes (1)

  • Percent change in HDL-cholesterol level

    8 weeks

Secondary Outcomes (15)

  • 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

  • +10 more secondary outcomes

Study Arms (3)

DLBS1449, 1x75 mg

EXPERIMENTAL

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

Drug: DLBS1449

DLBS1449, 1x150 mg

EXPERIMENTAL

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

Drug: DLBS1449

Placebo

PLACEBO COMPARATOR

Placebo once daily, taken every day along the study period

Other: Placebo

Interventions

DLBS1449DRUG

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.

Also known as: Forhidrol
DLBS1449, 1x150 mgDLBS1449, 1x75 mg
PlaceboOTHER

Placebo will be given every day for 8 weeks.

Placebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Surabaya, East Java, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

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

    Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

October 30, 2013

Study Start

July 1, 2016

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

ID(1)