CompletedPhase 4

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

Indonesia122 participantsStarted 2013-05

Plain-language 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.

Who can participate

Age range25 Years – 65 Years

SexALL

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Exclusion criteria

✕. For females of childbearing potential: Pregnancy, breast-feeding, the intention of becoming pregnant.
✕. 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

What they're measuring

Fibrinogen level reduction

Timeframe: 8 weeks

Trial details

NCT IDNCT01865474

SponsorDexa Medica Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials