Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01865474|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : August 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: DLBS1033 Drug: placebo tablet of DLBS1033||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Treatment I
DLBS1033 bioactive fraction tablet 490 mg thrice daily
1 DLBS1033 tablet 490 mg thrice daily for 2 months
Other Name: Disolf
Experimental: Treatment II
Placebo tablet of DLBS1033, thrice daily
Drug: placebo tablet of DLBS1033
1 placebo tablet of DLBS1033 thrice daily for 2 months
Other Name: placebo tablet of Disolf
- Fibrinogen level reduction [ Time Frame: 8 weeks ]Fibrinogen level reduction from baseline to the end of study (Week 8th)
- Change of D-dimer [ Time Frame: 4 weeks and 8 weeks ]Change of D-dimer from baseline to every follow-up visit
- Change of von Willebrand Factor activity [ Time Frame: 4 weeks and 8 weeks ]Change of von Willebrand Factor activity from baseline to every follow-up visit.
- Change of hs-CRP level [ Time Frame: 4 weeks and 8 weeks ]Change of hs-CRP level from baseline to every follow-up visit.
- Change of HbA1c [ Time Frame: 8 weeks ]Change of HbA1c from baseline to end of study (Week 8th).
- Liver function [ Time Frame: 8 weeks ]Liver function (serum ALT, AST,γ-glutamyl transferase, alkaline phosphatase) at baseline and end of study (Week 8th)
- Renal function [ Time Frame: 8 weeks ]Renal function (serum creatinine, BUN) at baseline and end of study (Week 8th)
- Prothrombin Time (PT) [ Time Frame: 4 weeks and 8 weeks ]Prothrombin time from baseline to every follow-up visit
- Activated partial thromboplastin time (aPTT) [ Time Frame: 4 weeks and 8 weeks ]Activated partial thromboplastin time (aPTT)from baseline to every follow-up visit
- Adverse events [ Time Frame: 4 weeks and 8 weeks (during 8 weeks) ]Adverse events (mainly: GI bleeding, and other bleeding events) from baseline to every follow-up visit
- Change of Thromboxane-B2 level [ Time Frame: 4 weeks and 8 weeks ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865474
|Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital|
|Padang, Sumatera Barat, Indonesia|
|Principal Investigator:||Asman Manaf, Prof. Dr. dr., SpPD-KEMD||Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital, Padang, Sumatera Barat, Indonesia|