DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes; Peripheral Arterial Disease
• Intervention / Treatment: Drug: DLBS1033; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia
      • Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
    • Denpasar, Bali, Indonesia
      • Department of Internal Medicine, RSUD Wangaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLBS1033; DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period	Drug: 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; Other Names: Disolf
Placebo Comparator: Placebo; Placebo tablet is administered one tablet three times daily, every day for twelve weeks of study period	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting ankle-brachial index (ABI)	The change of resting ABI	Week 0 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting ABI	The change of resting ABI	Week 0 and 6
hs-CRP	The change of hs-CRP	Week 0, 6, and 12
Thromboxane B2	The change of thromboxane B2	Week 0, 6, and 12
Fibrinogen	The change of fibrinogen	Week 0, 6, and 12
d-dimer	The change of d-dimer	Week 0, 6, and 12
Routine hematology	Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count	Week 0, 6, and 12
Liver function	Liver function measured includes: serum ALT, AST, and alkaline phosphatase	Week 0 and 12
Renal function	Renal function measured includes: serum creatinine and blood urea nitrogen (BUN)	Week 0 and 12
Haemostasis parameters	Haemostasis parameters measured includes: prothrombin time (PT) and activated partial thromboplastin time (aPTT)	Week 0, 6, and 12
Adverse events	Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study	Week 0 - 12

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Ketut Suastika, Prof, SpPD, MD, Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Ankle-brachial index; DLBS1033
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: DLBS1033-0312