Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865474
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: DLBS1033 Drug: placebo tablet of DLBS1033 Phase 4

Detailed Description:

There will be 2 groups of treatment, each consisting of 68 subjects, with the treatment regimens as the following:

Treatment I : DLBS1033 bioactive fraction tablet @ 490 mg, three times daily. Treatment II : Placebo tablet of DLBS1033, three times daily.

Clinical examination to evaluate the efficacy of the investigational drug will be performed at baseline and every follow-up visit (at interval of 4 weeks) over the 8 weeks of study period. All subjects will be advised to follow such a lifestyle modification throughout the study period.

All subjects will be under direct supervision of a medical doctor during the study period.

During the study period, anti-diabetes treatment taken by study subjects should still be continued. Other treatment related to subjects' concomitant illnesses, such as hypertension, and/or dyslipidemia, is allowed during subjects' participation in the study.

Other medication such as anti-platelets, fibrinolytic agents and anti-coagulants, or other treatment including herbals/alternatives which may affect haemostatic system, are not allowed to be used during the study period.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus
Study Start Date : May 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment I
DLBS1033 bioactive fraction tablet 490 mg thrice daily
Drug: DLBS1033
1 DLBS1033 tablet 490 mg thrice daily for 2 months
Other Name: Disolf

Experimental: Treatment II
Placebo tablet of DLBS1033, thrice daily
Drug: placebo tablet of DLBS1033
1 placebo tablet of DLBS1033 thrice daily for 2 months
Other Name: placebo tablet of Disolf




Primary Outcome Measures :
  1. Fibrinogen level reduction [ Time Frame: 8 weeks ]
    Fibrinogen level reduction from baseline to the end of study (Week 8th)


Secondary Outcome Measures :
  1. Change of D-dimer [ Time Frame: 4 weeks and 8 weeks ]
    Change of D-dimer from baseline to every follow-up visit

  2. Change of von Willebrand Factor activity [ Time Frame: 4 weeks and 8 weeks ]
    Change of von Willebrand Factor activity from baseline to every follow-up visit.

  3. Change of hs-CRP level [ Time Frame: 4 weeks and 8 weeks ]
    Change of hs-CRP level from baseline to every follow-up visit.

  4. Change of HbA1c [ Time Frame: 8 weeks ]
    Change of HbA1c from baseline to end of study (Week 8th).

  5. Liver function [ Time Frame: 8 weeks ]
    Liver function (serum ALT, AST,γ-glutamyl transferase, alkaline phosphatase) at baseline and end of study (Week 8th)

  6. Renal function [ Time Frame: 8 weeks ]
    Renal function (serum creatinine, BUN) at baseline and end of study (Week 8th)

  7. Prothrombin Time (PT) [ Time Frame: 4 weeks and 8 weeks ]
    Prothrombin time from baseline to every follow-up visit

  8. Activated partial thromboplastin time (aPTT) [ Time Frame: 4 weeks and 8 weeks ]
    Activated partial thromboplastin time (aPTT)from baseline to every follow-up visit

  9. Adverse events [ Time Frame: 4 weeks and 8 weeks (during 8 weeks) ]
    Adverse events (mainly: GI bleeding, and other bleeding events) from baseline to every follow-up visit

  10. Change of Thromboxane-B2 level [ Time Frame: 4 weeks and 8 weeks ]
    Change of Thromboxane-B2 level from baseline to every follow-up visit (as an indirect indicator to assess the effect of study treatment on TxA2)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. 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.
  2. The presence of clinically significant electrocardiographic abnormality
  3. History of acute coronary syndrome (myocardial infarction, stroke, unstable angina pectoris), peripheral arterial diseases, venous thromboembolism or other cardiovascular events.
  4. History of other arteriosclerotic disease necessitating medical or pharmacological treatment.
  5. Severe hypertension (systolic blood pressure ≥ 180 mm Hg, diastolic ≥ 110 mm Hg).
  6. Treatment with antiplatelets or antithrombotic agents, including other oral lumbrokinase products within 14 days prior to Screening.
  7. Subjects with prior experience with DLBS1033.
  8. Subjects with high-risk of bleeding
  9. Presence of malignancies as observed clinically or by anamnesis.
  10. 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.
  11. Subjects with known or suspected allergy to study medication or similar products.
  12. Subjects with concurrent herbal (alternative) medicines or food supplements suspected to have effect on the primary efficacy endpoint.
  13. Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865474


Locations
Layout table for location information
Indonesia
Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital
Padang, Sumatera Barat, Indonesia
Sponsors and Collaborators
Dexa Medica Group
Investigators
Layout table for investigator information
Principal Investigator: 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

Layout table for additonal information
Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01865474     History of Changes
Other Study ID Numbers: DLBS1033-0212
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Keywords provided by Dexa Medica Group:
DLBS1033, Type 2 DM, fibrinolytic, hypercoagulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases