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Clinical Trial Details

Trial ID: L4817
Source ID: NCT01472614
Associated Drug: Dlbs3233
Title: Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type-2 Diabetes Mellitus
Interventions: DRUG: DLBS3233
Outcome Measures: Primary: Reduction of A1c level, Reduction of A1c level from baseline after 12 weeks of treatment, 12 weeks | Secondary: Reduction of venous A1c level, Reduction of venous A1c level from baseline to 6 weeks of treatment, 6 weeks|Reduction of venous FPG, Reduction of venous FPG from baseline to every evaluation-time point, 6 and 12 weeks|Reduction of venous 1h-PG, Reduction of venous 1 hour-post prandial plasma glucose from baseline to every evaluation-time point, 6 and 12 weeks|Change in fasting insulin level, Change in fasting insulin level from baseline to every evaluation-time point, 6 and 12 weeks|Change in HOMA-R, Change in HOMA-R from baseline to every evaluation-time point, 6 and 12 weeks|Change in HOMA-B, Change in HOMA-B from baseline to every evaluation-time point, 6 and 12 weeks|Change in adiponectin level, Change in adiponectin level from baseline to every evaluation-time point, 6 and 12 weeks|Change in lipid profile, Change in lipid profile from baseline to every evaluation-time point, including: LDL-cholesterol (direct), HDL-cholesterol, total cholesterol, and triglycerides, 6 and 12 weeks|Change in body weight, Change in body weight from baseline to every evaluation-time point, 6 and 12 weeks|Hematology, Hematology parameters (Hemoglobin level, Hematocrit, Red Blood Cell count, White Blood Cell count as well as its differentials, and platelet count) will be evaluated at baseline, at interval of 6 weeks, and at the end of study, 6 and 12 weeks|Liver function, Liver function parameters (serum ALT, serum AST, gamma-glutamyl transferase, alkaline phosphatase, and total bilirubin levels) will be measured at baseline, at interval of 6 weeks, and at the end of study, 6 and 12 weeks|Renal function, Renal function parameter, i.e. serum creatinine level will be measured at baseline, at interval of 6 weeks, and at the end of study, 6 and 12 weeks|Adverse events, Adverse events as well as number of subjects experienced the events will be observed and evaluated during the study period (12 weeks) and until all adverse events have been recovered or stabilized., 1-12 weeks
Sponsor/Collaborators: Sponsor: Dexa Medica Group
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 54
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-09
Completion Date: 2013-04
Results First Posted:
Last Update Posted: 2013-05-27
Locations: Private Clinic at Jl. Prof. Dr. Moestopo 164, Surabaya, East Java, Indonesia|Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital, Surabaya, East Java, Indonesia
URL: https://clinicaltrials.gov/show/NCT01472614