drugset / Trial / NCT01865474

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

NCT01865474

Phase 4 Completed 122 enrolled Dexa Medica Group
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-05
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS1033 Protein / enzyme biologic 490 mg