DiabetesPhase 2/3NCT02145988
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
A Phase 2/3 study testing DLBS1033 in people with Diabetes and Peripheral Arterial Disease, run by Dexa Medica Group at 2 sites in Indonesia.
Trial summary
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes, Peripheral Arterial Disease
- What is being tested?
- DLBS1033
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesIndonesia
- Study dates
- 3 Jun 2015to Jul 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent before any trial related activities.
- Male or female subjects of 40 - 65 years of age.
- Diagnosis of diabetes mellitus defined as HbA1c level of ≥ 6.5% (for newly diagnosed diabetes) or based on medical history.
- Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of 0.41-0.90 inclusive
Who cannot join
- Females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant.
- Recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome, coronary artery bypass surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA)/stent within 3 (three) months prior to screening.
- Impaired liver function: serum ALT > 2.5 times upper limit of normal.
- Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.
- Concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication.
- Subjects with concurrent herbal (alternative) medicines or food supplements
Show all 11Show fewer
- Subjects with any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.
- Subjects with high risk of bleeding:
- Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.
- Subjects with known or suspected allergy to any of study medications used in the study, including other lumbrokinase products.
- Subjects with known or suspected allergy or resistant to aspirin.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
Denpasar, Bali
Department of Internal Medicine, RSUD Wangaya
Denpasar, Bali
About this study
Official title: Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin treatment will augment significantly the resting ABI in diabetes patient with PAD in comparison with that of aspirin alone.
Read the detailed description
Subjects in this study will be screened consecutively and eligible subjects will be randomized to receive aspirin tablet 80 mg once daily and either the investigational drug (DLBS1033 tablet 490 mg three times daily) or its placebo, for 12 weeks.
Diabetic subjects who have been being under therapy with aspirin can directly start with study treatment. For those who are currently not under therapy with aspirin, there will be a run-in period during which they will receive (or be switched to) aspirin treatment, for two weeks. After then, they will receive study medication.
Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at the interval of six weeks over the twelve week-course of therapy.
- Conditions
- Diabetes, Peripheral Arterial Disease
- Being tested
- DLBS1033, Placebo
- Keywords
- DLBS1033, Peripheral arterial disease, Ankle-brachial index
- Medical subject headings
- Diabetes Mellitus, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS1033Drug
Also called Disolf
Investigational drug or placebo will be given in addition to the standard therapy: aspirin at the dose of 80 mg, once daily, every day for twelve weeks of study period
PlaceboDrug
Investigational drug or placebo will be given in addition to the standard therapy: aspirin at the dose of 80 mg, once daily, every day for twelve weeks of study period
| Study group | Role | What they receive |
|---|---|---|
| DLBS1033 | Experimental | DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period Receives: Drug: DLBS1033 |
| Placebo | Placebo comparator | Placebo tablet is administered one tablet three times daily, every day for twelve weeks of study period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting ankle-brachial index (ABI)
The change of resting ABI
Measured: Week 0 and 12
Secondary outcomes (10)
Resting ABI
The change of resting ABI
Measured: Week 0 and 6
hs-CRP
The change of hs-CRP
Measured: Week 0, 6, and 12
Thromboxane B2
The change of thromboxane B2
Measured: Week 0, 6, and 12
Fibrinogen
The change of fibrinogen
Measured: Week 0, 6, and 12
d-dimer
The change of d-dimer
Measured: Week 0, 6, and 12
Routine hematology
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
Measured: Week 0, 6, and 12
Liver function
Liver function measured includes: serum ALT, AST, and alkaline phosphatase
Measured: Week 0 and 12
Renal function
Renal function measured includes: serum creatinine and blood urea nitrogen (BUN)
Measured: Week 0 and 12
Haemostasis parameters
Haemostasis parameters measured includes: prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Measured: Week 0, 6, and 12
Adverse events
Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study
Measured: Week 0 - 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study start3 Jun 2015
- Primary completionJun 2018
- Study completionJul 2018
Why it stopped: Recruitment rate is unexpectedly too low (insufficient number of eligible patients).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ketut Suastika, Prof, SpPD, MD, Principal investigator, Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145988
- Sponsor's protocol ID
- DLBS1033-0312
- Status last verified
- Jul 2018
- First submitted
- 21 May 2014
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT02145988
- Acronym / sponsor ID
- DLBS1033-0312
- Conditions
- Diabetes, Peripheral Arterial Disease
- Keywords
- DLBS1033, Peripheral arterial disease, Ankle-brachial index
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment rate is unexpectedly too low (insufficient number of eligible patients).
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 23 May 2014 (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 prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin treatment will augment significantly the resting ABI in diabetes patient with PAD in comparison with that of aspirin alone.
Detailed description
Subjects in this study will be screened consecutively and eligible subjects will be randomized to receive aspirin tablet 80 mg once daily and either the investigational drug (DLBS1033 tablet 490 mg three times daily) or its placebo, for 12 weeks.
Diabetic subjects who have been being under therapy with aspirin can directly start with study treatment. For those who are currently not under therapy with aspirin, there will be a run-in period during which they will receive (or be switched to) aspirin treatment, for two weeks. After then, they will receive study medication.
Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at the interval of six weeks over the twelve 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
- 2
| Arm | Type | Receives |
|---|---|---|
| DLBS1033 | Experimental | Drug: DLBS1033DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet is administered one tablet three times daily, every day for twelve weeks of study period |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent before any trial related activities.
- Male or female subjects of 40 - 65 years of age.
- Diagnosis of diabetes mellitus defined as HbA1c level of ≥ 6.5% (for newly diagnosed diabetes) or based on medical history.
- Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of 0.41-0.90 inclusive
Key exclusion criteria (11 listed)
- Females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant.
- Recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome, coronary artery bypass surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA)/stent within 3 (three) months prior to screening.
- Impaired liver function: serum ALT > 2.5 times upper limit of normal.
- Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.
- Concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication.
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 |
|---|---|---|
| DLBS1033Also: DisolfInvestigational drug or placebo will be given in addition to the standard therapy: aspirin at the dose of 80 mg, once daily, every day for twelve weeks of study period | Drug | DLBS1033 |
| PlaceboInvestigational drug or placebo will be given in addition to the standard therapy: aspirin at the dose of 80 mg, once daily, every day for twelve weeks of study period | Drug | Placebo |
Primary outcome
Resting ankle-brachial index (ABI)
Time frame: Week 0 and 12
The change of resting ABI
10 secondary outcomes
Resting ABI
Time frame: Week 0 and 6
hs-CRP
Time frame: Week 0, 6, and 12
Thromboxane B2
Time frame: Week 0, 6, and 12
Fibrinogen
Time frame: Week 0, 6, and 12
d-dimer
Time frame: Week 0, 6, and 12
Routine hematology
Time frame: Week 0, 6, and 12
Liver function
Time frame: Week 0 and 12
Renal function
Time frame: Week 0 and 12
Haemostasis parameters
Time frame: Week 0, 6, and 12
Adverse events
Time frame: Week 0 - 12
Results and safety
The study was stopped early (reason given: Recruitment rate is unexpectedly too low (insufficient number of eligible patients).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
Ketut Suastika, Prof, SpPD, MD principal investigator
Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
2 sites 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 DLBS1033 in people with Diabetes and Peripheral Arterial Disease, run by Dexa Medica Group at 2 sites 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: Recruitment rate is unexpectedly too low (insufficient number of eligible patients).). Results are not available in the source record.
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?
Resting ankle-brachial index (ABI) (time frame: Week 0 and 12). 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 26 Jul 2018.