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Clinical Trial Details

Trial ID: L2307
Source ID: NCT01865474
Associated Drug: Dlbs1033
Title: Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: DLBS1033|DRUG: placebo tablet of DLBS1033
Outcome Measures: Primary: Fibrinogen level reduction, Fibrinogen level reduction from baseline to the end of study (Week 8th), 8 weeks | Secondary: Change of D-dimer, Change of D-dimer from baseline to every follow-up visit, 4 weeks and 8 weeks|Change of von Willebrand Factor activity, Change of von Willebrand Factor activity from baseline to every follow-up visit., 4 weeks and 8 weeks|Change of hs-CRP level, Change of hs-CRP level from baseline to every follow-up visit., 4 weeks and 8 weeks|Change of HbA1c, Change of HbA1c from baseline to end of study (Week 8th)., 8 weeks|Liver function, Liver function (serum ALT, AST,γ-glutamyl transferase, alkaline phosphatase) at baseline and end of study (Week 8th), 8 weeks|Renal function, Renal function (serum creatinine, BUN) at baseline and end of study (Week 8th), 8 weeks|Prothrombin Time (PT), Prothrombin time from baseline to every follow-up visit, 4 weeks and 8 weeks|Activated partial thromboplastin time (aPTT), Activated partial thromboplastin time (aPTT)from baseline to every follow-up visit, 4 weeks and 8 weeks|Adverse events, Adverse events (mainly: GI bleeding, and other bleeding events) from baseline to every follow-up visit, 4 weeks and 8 weeks (during 8 weeks)|Change of Thromboxane-B2 level, 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), 4 weeks and 8 weeks
Sponsor/Collaborators: Sponsor: Dexa Medica Group
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 122
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-05
Completion Date: 2016-06
Results First Posted:
Last Update Posted: 2016-08-04
Locations: Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital, Padang, Sumatera Barat, Indonesia
URL: https://clinicaltrials.gov/show/NCT01865474