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

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.

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

• 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.