Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus

NCT01865474 | Completed Phase 4

• 1 other identifier: DLBS1033-0212
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, double-blind, randomized, and controlled study. The investigational product, DLBS1033 at a dose of 490 mg thrice daily or placebo, will be given for an 8-week course of therapy. DLBS1033 effectively demonstrated fibrinolytic, fibrinogenolytic as well as antithrombotic activities. Hypercoagulation state with high fibrinogen level is usually found in diabetes mellitus patients. Therefore, the hypothesis of interest of this study is that DLBS1033 will reduce fibrinogen level of diabetes mellitus patients better than that of the Control Group.

Conditions

Type 2 Diabetes Mellitus

Keywords

DLBS1033, Type 2 DM, fibrinolytic, hypercoagulation

Outcome Measures

Primary Outcomes (1)

• Fibrinogen level reduction

  Fibrinogen level reduction from baseline to the end of study (Week 8th)

  8 weeks

Secondary Outcomes (10)

• Change of D-dimer

  4 weeks and 8 weeks

• Change of von Willebrand Factor activity

  4 weeks and 8 weeks

• Change of hs-CRP level

  4 weeks and 8 weeks

• Change of HbA1c

  8 weeks

• Liver function

  8 weeks

Study Arms (2)

Treatment I

EXPERIMENTAL

DLBS1033 bioactive fraction tablet 490 mg thrice daily

Drug: DLBS1033

Treatment II

EXPERIMENTAL

Placebo tablet of DLBS1033, thrice daily

Drug: placebo tablet of DLBS1033

Interventions

DLBS1033 DRUG

1 DLBS1033 tablet 490 mg thrice daily for 2 months

Also known as: Disolf

Treatment I

placebo tablet of DLBS1033 DRUG

1 placebo tablet of DLBS1033 thrice daily for 2 months

Also known as: placebo tablet of Disolf

Treatment II

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as type 2 diabetes mellitus with A1c \> 7.0% at Screening.
• Men or women, between 25-65 years of age.
• Have been being treated with lifestyle intervention and/or any oral anti-diabetic agents and/or insulin.
• Adequate liver function: ALT and AST ≤ 2.5 times upper limit of normal.
• Adequate renal function: serum creatinine \< 2.0 times upper limit of normal.
• Able to take oral medication.

You may not qualify if:

• For females of childbearing potential: Pregnancy, breast-feeding, the intention of becoming pregnant.
• Patients must accept pregnancy tests during the trial if menstrual cycle is missed.
• Fertile patients must use a reliable and effective contraceptive.
• The presence of clinically significant electrocardiographic abnormality
• History of acute coronary syndrome (myocardial infarction, stroke, unstable angina pectoris), peripheral arterial diseases, venous thromboembolism or other cardiovascular events.
• History of other arteriosclerotic disease necessitating medical or pharmacological treatment.
• Severe hypertension (systolic blood pressure ≥ 180 mm Hg, diastolic ≥ 110 mm Hg).
• Treatment with antiplatelets or antithrombotic agents, including other oral lumbrokinase products within 14 days prior to Screening.
• Subjects with prior experience with DLBS1033.
• Subjects with high-risk of bleeding
• Presence of malignancies as observed clinically or by anamnesis.
• Subjects with any other disease state, including chronic or acute systemic infections, or uncontrolled illnesses, which judged by the investigator, could interfere with trial participation or trial evaluation.
• Subjects with known or suspected allergy to study medication or similar products.
• Subjects with concurrent herbal (alternative) medicines or food supplements suspected to have effect on the primary efficacy endpoint.
• Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening.

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital

Padang, West Sumatra, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Thrombophilia

Interventions

DLBS 1033

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Asman Manaf, Prof. Dr. dr., SpPD-KEMD

  Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital, Padang, Sumatera Barat, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

ID (1)