Clinical trial NCT01865474: Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus
Official title: DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: DLBS1033, Type 2 DM, fibrinolytic, hypercoagulation
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 122
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fibrinogen level reduction
timeFrame: 8 weeks
Secondary outcomes:
measure: Change of D-dimer
timeFrame: 4 weeks and 8 weeks
measure: Change of von Willebrand Factor activity
timeFrame: 4 weeks and 8 weeks
measure: Change of hs-CRP level
timeFrame: 4 weeks and 8 weeks
measure: Change of HbA1c
timeFrame: 8 weeks
measure: Liver function
timeFrame: 8 weeks
measure: Renal function
timeFrame: 8 weeks
measure: Prothrombin Time (PT)
timeFrame: 4 weeks and 8 weeks
measure: Activated partial thromboplastin time (aPTT)
timeFrame: 4 weeks and 8 weeks
measure: Adverse events
timeFrame: 4 weeks and 8 weeks (during 8 weeks)
measure: Change of Thromboxane-B2 level
timeFrame: 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Padang
country: Indonesia
facility: Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital
state: Sumatera Barat
Study officials:
affiliation: Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital, Padang, Sumatera Barat, Indonesia
name: Asman Manaf, Prof. Dr. dr., SpPD-KEMD
role: PRINCIPAL_INVESTIGATOR
References: