Status:
COMPLETED
Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Dexa Medica Group
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-65 years
Phase:
PHASE4
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....
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. Treatm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01865474
Start Date
May 1 2013
End Date
June 1 2016
Last Update
August 4 2016
Active Locations (1)
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1
Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital
Padang, West Sumatra, Indonesia