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Type 2 Diabetes MellitusPhase 4NCT01865474

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

A Phase 4 study testing DLBS1033 in people with Type 2 Diabetes Mellitus, run by Dexa Medica Group at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
DLBS1033
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
1 siteIndonesia
Study dates
May 2013to Jun 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

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

    Padang, West Sumatra

Other trials in Indonesia

About this study

Official title: DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus

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.

Read the 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.

Being tested
DLBS1033, placebo tablet of DLBS1033
Keywords
DLBS1033, Type 2 DM, fibrinolytic, hypercoagulation
Medical subject headings
Diabetes Mellitus, Type 2, Thrombophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DLBS1033Drug

    Also called Disolf

    1 DLBS1033 tablet 490 mg thrice daily for 2 months

  • placebo tablet of DLBS1033Drug

    Also called placebo tablet of Disolf

    1 placebo tablet of DLBS1033 thrice daily for 2 months

Study groups in NCT01865474
Study groupRoleWhat they receive
Treatment IExperimentalDLBS1033 bioactive fraction tablet 490 mg thrice daily
Receives: Drug: DLBS1033
Treatment IIExperimentalPlacebo tablet of DLBS1033, thrice daily
Receives: Drug: placebo tablet of DLBS1033

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fibrinogen level reduction

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

    Measured: 8 weeks

Secondary outcomes (10)

  1. Change of D-dimer

    Change of D-dimer from baseline to every follow-up visit

    Measured: 4 weeks and 8 weeks

  2. Change of von Willebrand Factor activity

    Change of von Willebrand Factor activity from baseline to every follow-up visit.

    Measured: 4 weeks and 8 weeks

  3. Change of hs-CRP level

    Change of hs-CRP level from baseline to every follow-up visit.

    Measured: 4 weeks and 8 weeks

  4. Change of HbA1c

    Change of HbA1c from baseline to end of study (Week 8th).

    Measured: 8 weeks

  5. Liver function

    Liver function (serum ALT, AST,γ-glutamyl transferase, alkaline phosphatase) at baseline and end of study (Week 8th)

    Measured: 8 weeks

  6. Renal function

    Renal function (serum creatinine, BUN) at baseline and end of study (Week 8th)

    Measured: 8 weeks

  7. Prothrombin Time (PT)

    Prothrombin time from baseline to every follow-up visit

    Measured: 4 weeks and 8 weeks

  8. Activated partial thromboplastin time (aPTT)

    Activated partial thromboplastin time (aPTT)from baseline to every follow-up visit

    Measured: 4 weeks and 8 weeks

  9. Adverse events

    Adverse events (mainly: GI bleeding, and other bleeding events) from baseline to every follow-up visit

    Measured: 4 weeks and 8 weeks (during 8 weeks)

  10. Change of Thromboxane-B2 level

    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)

    Measured: 4 weeks and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01865474
Sponsor's protocol ID
DLBS1033-0212
Status last verified
Aug 2016
First submitted
28 May 2013
Last updated
4 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DLBS1033 in people with Type 2 Diabetes Mellitus, run by Dexa Medica Group at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fibrinogen level reduction (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01865474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.

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