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Clinical Trial Details

Trial ID: L6005
Source ID: NCT01645332
Associated Drug: Placebo Of Dlbs3233
Title: Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type-2-diabetes Mellitus|New Onset
Interventions: DRUG: Placebo of DLBS3233|DRUG: DLBS3233|OTHER: Lifestyle modification
Outcome Measures: Primary: Reduction of A1c level, Reduction of A1c level from baseline to Week 12 of treatment, 12 weeks | Secondary: Reduction of venous FPG, Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment, 6 weeks and 12 weeks|Reduction of venous 2h-PG, Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment, 6 weeks and 12 weeks|Response rate, Percentage of subjects with FPG \< 110 mg/dL and/or reduction of at least 10% in FPG level from baseline to Week 12 of treatment, 12 weeks|Change in fasting insulin level, Change in fasting insulin level from baseline to Week 12 of treatment, 12 weeks|Change in HOMA-IR, Change in HOMA-IR from baseline to Week 12 of treatment, 12 weeks|Change in HOMA-B, Change in HOMA-B from baseline to Week 12 of treatment, 12 weeks|Change in adiponectin level, Change in adiponectin level from baseline to Week 12 of treatment, 12 weeks|Change in lipid profile, Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment, 12 weeks|Change in body weight, Change in body weight from baseline to Week 6 and Week 12 of treatment, 6 weeks and 12 weeks|Vital signs, Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12, 6 weeks and 12 weeks|Liver function, Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12, 12 weeks|Renal function, Renal function (serum creatinine level) will be evaluated at baseline and Week 12, 12 weeks|Electrocardiography (ECG), ECG will be evaluated at baseline and Week 12, 12 weeks|Adverse events, Adverse events as well as number of subjects experienced the events will be observed and evaluated throughout study period (12 weeks) and until all adverse events have been recovered or stabilized, 12 weeks
Sponsor/Collaborators: Sponsor: Dexa Medica Group
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 104
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-07
Completion Date: 2014-09
Results First Posted:
Last Update Posted: 2014-10-08
Locations: Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital, Semarang, Jawa Tengah, 50231, Indonesia
URL: https://clinicaltrials.gov/show/NCT01645332