NCT01865474

Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus

DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DLBS1033	1 DLBS1033 tablet 490 mg thrice daily for 2 months
DRUG	placebo tablet of DLBS1033	1 placebo tablet of DLBS1033 thrice daily for 2 months

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-05-31
• Last updated: 2016-08-04

Locations

1 site across 1 country: Indonesia