Who is sponsoring NCT01865474?

NCT01865474 is sponsored by Dexa Medica Group.

What condition does NCT01865474 study?

NCT01865474 studies Type 2 Diabetes Mellitus.

What drugs are being tested in NCT01865474?

Interventions: DLBS1033, placebo tablet of DLBS1033.

What is the status of NCT01865474?

NCT01865474 is currently COMPLETED.

Last reviewed 2016-08-03 · How we verify

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

NCT01865474 Phase 4 COMPLETED

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.

Details

Lead sponsor	Dexa Medica Group
Phase	Phase 4
Status	COMPLETED
Enrolment	122
Start date	2013-05
Completion	2016-06

Conditions

Type 2 Diabetes Mellitus

Interventions

DLBS1033
placebo tablet of DLBS1033

Primary outcomes

Fibrinogen level reduction — 8 weeks
Fibrinogen level reduction from baseline to the end of study (Week 8th)

Countries

Indonesia