Back to resultsDLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
Primary Purpose
Diabetes, Peripheral Arterial Disease
Status
Terminated
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
DLBS1033
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring DLBS1033, Peripheral arterial disease, Ankle-brachial index
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
- Department of Internal Medicine, RSUD Wangaya
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DLBS1033
Placebo
Arm Description
DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period
Placebo tablet is administered one tablet three times daily, every day for twelve weeks of study period
Outcomes
Primary Outcome Measures
Resting ankle-brachial index (ABI)
The change of resting ABI
Secondary Outcome Measures
Resting ABI
The change of resting ABI
hs-CRP
The change of hs-CRP
Thromboxane B2
The change of thromboxane B2
Fibrinogen
The change of fibrinogen
d-dimer
The change of d-dimer
Routine hematology
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
Liver function
Liver function measured includes: serum ALT, AST, and alkaline phosphatase
Renal function
Renal function measured includes: serum creatinine and blood urea nitrogen (BUN)
Haemostasis parameters
Haemostasis parameters measured includes: prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Adverse events
Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02145988
Brief Title
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
Official Title
Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment rate is unexpectedly too low (insufficient number of eligible patients).
Study Start Date
June 3, 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Peripheral Arterial Disease
Keywords
DLBS1033, Peripheral arterial disease, Ankle-brachial index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DLBS1033
Arm Type
Experimental
Arm Description
DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet is administered one tablet three times daily, every day for twelve weeks of study period
Intervention Type
Drug
Intervention Name(s)
DLBS1033
Other Intervention Name(s)
Disolf
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Resting ankle-brachial index (ABI)
Description
The change of resting ABI
Time Frame
Week 0 and 12
Secondary Outcome Measure Information:
Title
Resting ABI
Description
The change of resting ABI
Time Frame
Week 0 and 6
Title
hs-CRP
Description
The change of hs-CRP
Time Frame
Week 0, 6, and 12
Title
Thromboxane B2
Description
The change of thromboxane B2
Time Frame
Week 0, 6, and 12
Title
Fibrinogen
Description
The change of fibrinogen
Time Frame
Week 0, 6, and 12
Title
d-dimer
Description
The change of d-dimer
Time Frame
Week 0, 6, and 12
Title
Routine hematology
Description
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
Time Frame
Week 0, 6, and 12
Title
Liver function
Description
Liver function measured includes: serum ALT, AST, and alkaline phosphatase
Time Frame
Week 0 and 12
Title
Renal function
Description
Renal function measured includes: serum creatinine and blood urea nitrogen (BUN)
Time Frame
Week 0 and 12
Title
Haemostasis parameters
Description
Haemostasis parameters measured includes: prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Time Frame
Week 0, 6, and 12
Title
Adverse events
Description
Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study
Time Frame
Week 0 - 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketut Suastika, Prof, SpPD, MD
Organizational Affiliation
Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
City
Denpasar
State/Province
Bali
Country
Indonesia
Facility Name
Department of Internal Medicine, RSUD Wangaya
City
Denpasar
State/Province
Bali
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
We'll reach out to this number within 24 hrs