Type 2 Diabetes Mellitus Clinical Trial
Official title:
DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus
Verified date | August 2016 |
Source | Dexa Medica Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 122 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 65 Years |
Eligibility |
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: 1. 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. 2. The presence of clinically significant electrocardiographic abnormality 3. History of acute coronary syndrome (myocardial infarction, stroke, unstable angina pectoris), peripheral arterial diseases, venous thromboembolism or other cardiovascular events. 4. History of other arteriosclerotic disease necessitating medical or pharmacological treatment. 5. Severe hypertension (systolic blood pressure = 180 mm Hg, diastolic = 110 mm Hg). 6. Treatment with antiplatelets or antithrombotic agents, including other oral lumbrokinase products within 14 days prior to Screening. 7. Subjects with prior experience with DLBS1033. 8. Subjects with high-risk of bleeding 9. Presence of malignancies as observed clinically or by anamnesis. 10. 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. 11. Subjects with known or suspected allergy to study medication or similar products. 12. Subjects with concurrent herbal (alternative) medicines or food supplements suspected to have effect on the primary efficacy endpoint. 13. Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital | Padang | Sumatera Barat |
Lead Sponsor | Collaborator |
---|---|
Dexa Medica Group |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibrinogen level reduction | Fibrinogen level reduction from baseline to the end of study (Week 8th) | 8 weeks | No |
Secondary | Change of D-dimer | Change of D-dimer from baseline to every follow-up visit | 4 weeks and 8 weeks | No |
Secondary | Change of von Willebrand Factor activity | Change of von Willebrand Factor activity from baseline to every follow-up visit. | 4 weeks and 8 weeks | No |
Secondary | Change of hs-CRP level | Change of hs-CRP level from baseline to every follow-up visit. | 4 weeks and 8 weeks | No |
Secondary | Change of HbA1c | Change of HbA1c from baseline to end of study (Week 8th). | 8 weeks | No |
Secondary | Liver function | Liver function (serum ALT, AST,?-glutamyl transferase, alkaline phosphatase) at baseline and end of study (Week 8th) | 8 weeks | Yes |
Secondary | Renal function | Renal function (serum creatinine, BUN) at baseline and end of study (Week 8th) | 8 weeks | Yes |
Secondary | Prothrombin Time (PT) | Prothrombin time from baseline to every follow-up visit | 4 weeks and 8 weeks | Yes |
Secondary | Activated partial thromboplastin time (aPTT) | Activated partial thromboplastin time (aPTT)from baseline to every follow-up visit | 4 weeks and 8 weeks | Yes |
Secondary | Adverse events | Adverse events (mainly: GI bleeding, and other bleeding events) from baseline to every follow-up visit | 4 weeks and 8 weeks (during 8 weeks) | Yes |
Secondary | 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) | 4 weeks and 8 weeks | No |
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