Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus (NCT01865474) | Clinical Trial Compass
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 range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.