Clinical trial NCT02145988: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Diabetes
Peripheral Arterial Disease
Keywords: DLBS1033
Peripheral arterial disease
Ankle-brachial index
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Resting ankle-brachial index (ABI)
timeFrame: Week 0 and 12
Secondary outcomes:
measure: Resting ABI
timeFrame: Week 0 and 6
measure: hs-CRP
timeFrame: Week 0, 6, and 12
measure: Thromboxane B2
timeFrame: Week 0, 6, and 12
measure: Fibrinogen
timeFrame: Week 0, 6, and 12
measure: d-dimer
timeFrame: Week 0, 6, and 12
measure: Routine hematology
timeFrame: Week 0, 6, and 12
measure: Liver function
timeFrame: Week 0 and 12
measure: Renal function
timeFrame: Week 0 and 12
measure: Haemostasis parameters
timeFrame: Week 0, 6, and 12
measure: Adverse events
timeFrame: Week 0 - 12
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
state: Bali
city: Denpasar
country: Indonesia
facility: Department of Internal Medicine, RSUD Wangaya
state: Bali
Study officials:
affiliation: Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
name: Ketut Suastika, Prof, SpPD, MD
role: PRINCIPAL_INVESTIGATOR
References: