DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

Diabetes Clinical Trial

Official title:

Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02145988
• Other study ID #: DLBS1033-0312
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 3, 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Dexa Medica Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
Indonesia	Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital	Denpasar	Bali
Indonesia	Department of Internal Medicine, RSUD Wangaya	Denpasar	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

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