DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

NCT ID: NCT02145988

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-03
• Study Completion Date: 2018-07-31

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.

Conditions

Diabetes; Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DLBS1033

DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period

Group Type: EXPERIMENTAL

DLBS1033

Intervention Type: DRUG

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

Placebo

Placebo tablet is administered one tablet three times daily, every day for twelve weeks of study period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

DLBS1033

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

Placebo

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

Other Intervention Names

Disolf

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ketut Suastika, Prof, SpPD, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital

Locations

Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital

Denpasar, Bali, Indonesia

Department of Internal Medicine, RSUD Wangaya

Denpasar, Bali, Indonesia

Countries

Indonesia

Other Identifiers

DLBS1033-0312

Identifier Type: -

Identifier Source: org_study_id