Diabetic PatientsPhase 2/3NCT01972477
DLBS1449 in Diabetic Patients With Low HDL
A Phase 2/3 study testing DLBS1449 in people with Diabetic Patients and Low HDL-cholesterol (< 35 mg/dL), run by Dexa Medica Group at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetic Patients, Low HDL-cholesterol (< 35 mg/dL), Lifestyle Intervention for at Least 1 Month
- What is being tested?
- DLBS1449
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2016to Jan 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor
Surabaya, East Java
About this study
Official title: 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).
Read the 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
- Being tested
- DLBS1449, Placebo
- Keywords
- DLBS1449, diabetes mellitus, HDL-cholesterol
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS1449Drug
Also called Forhidrol
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.
PlaceboOther
Placebo will be given every day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DLBS1449, 1x75 mg | Experimental | DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period. Receives: Drug: DLBS1449 |
| DLBS1449, 1x150 mg | Experimental | DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period Receives: Drug: DLBS1449 |
| Placebo | Placebo comparator | Placebo once daily, taken every day along the study period Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in HDL-cholesterol level
Measured: 8 weeks
Secondary outcomes (15)
Percent change in HDL-cholesterol level
Measured: 4 and 8 weeks
Percent change in LDL-cholesterol level
Measured: 4 and 8 weeks
Percent change in sd LDL-cholesterol level
Measured: 4 and 8 weeks
Percent change in triglycerides level
Measured: 4 and 8 weeks
Percent change in total cholesterol level
Measured: 4 and 8 weeks
Change in Apo-A1
Measured: 4 and 8 weeks
Change in Apo-B
Measured: 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.
Measured: 8 weeks
Change in A1c level
Measured: 8 weeks
Vital signs
Vital signs measurements include: blood pressure, heart rate, and respiratory rate.
Measured: 4 and 8 weeks
Routine hematology
Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
Measured: 4 and 8 weeks
Liver function
Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase.
Measured: 4 and 8 weeks
Renal function
Renal function measurement includes: serum creatinine.
Measured: 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.
Measured: 8 weeks
Adverse event
Adverse event will be observed and recorded during the study period.
Measured: 1-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startJul 2016
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD, Principal investigator, Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972477
- Sponsor's protocol ID
- DLBS1449-0111
- Status last verified
- Aug 2016
- First submitted
- 24 Oct 2013
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo
- ClinicalTrials.gov ID
- NCT01972477
- Acronym / sponsor ID
- DLBS1449-0111
- Conditions
- Diabetic Patients, Low HDL-cholesterol (< 35 mg/dL), Lifestyle Intervention for at Least 1 Month
- Keywords
- DLBS1449, diabetes mellitus, HDL-cholesterol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DLBS1449, 1x75 mg | Experimental | Drug: DLBS1449DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period. |
| DLBS1449, 1x150 mg | Experimental | Drug: DLBS1449DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period |
| Placebo | Placebo comparator | Other: PlaceboPlacebo once daily, taken every day along the study period |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLBS1449Also: ForhidrolStudy 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. | Drug | DLBS1449, 1x150 mg, DLBS1449, 1x75 mg |
| PlaceboPlacebo will be given every day for 8 weeks. | Other | Placebo |
Primary outcome
Percent change in HDL-cholesterol level
Time frame: 8 weeks
15 secondary outcomes
Percent change in HDL-cholesterol level
Time frame: 4 and 8 weeks
Percent change in LDL-cholesterol level
Time frame: 4 and 8 weeks
Percent change in sd LDL-cholesterol level
Time frame: 4 and 8 weeks
Percent change in triglycerides level
Time frame: 4 and 8 weeks
Percent change in total cholesterol level
Time frame: 4 and 8 weeks
Change in Apo-A1
Time frame: 4 and 8 weeks
Change in Apo-B
Time frame: 4 and 8 weeks
Response rate
Time frame: 8 weeks
Change in A1c level
Time frame: 8 weeks
Vital signs
Time frame: 4 and 8 weeks
Routine hematology
Time frame: 4 and 8 weeks
Liver function
Time frame: 4 and 8 weeks
Renal function
Time frame: 4 and 8 weeks
Electrocardiography (ECG)
Time frame: 8 weeks
Adverse event
Time frame: 1-8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD principal investigator
Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DLBS1449 in people with Diabetic Patients and Low HDL-cholesterol (< 35 mg/dL), run by Dexa Medica Group at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in HDL-cholesterol level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.