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Clinical Trial Details

Trial ID: L6800
Source ID: NCT01531933
Associated Drug: Dlbs3233
Title: Efficacy and Safety of DLBS3233 in Prediabetic Patients
Acronym: DIPPER-DM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Prediabetic
Interventions: DRUG: DLBS3233|DRUG: Placebo of DLBS3233
Outcome Measures: Primary: Change in 15-minute post prandial insulin level, Change in 15-minute post prandial insulin level from baseline to 12 weeks of treatment, 12 weeks of treatment | Secondary: Change in 15-minute post prandial insulin level, Change in 15-minute post prandial insulin level from baseline to 8 weeks of treatment, 8 weeks of treatment|Change in 2-hour post prandial insulin level, Change in 2-hour post prandial insulin level from baseline to 8 weeks and to 12 weeks of treatment, 8 weeks and 12 weeks of treatment|Change in 15-minute post prandial plasma glucose, Change in 15-minute post prandial plasma glucose from baseline to 8 weeks and to 12 weeks of treatment, 8 weeks and 12 weeks of treatment|Change in 2-hour post prandial plasma glucose, Change in 2-hour post prandial plasma glucose from baseline to each study visit (4 weeks, 8 weeks, and 12 weeks of treatment), 4 weeks, 8 weeks, and 12 weeks of treatment|Change in HOMA-IR, Change in HOMA-IR from baseline to 8 weeks and to 12 weeks of treatment, 8 weeks and 12 weeks of treatment|Change in hs-CRP, Change in hs-CRP from baseline to 8 weeks and to 12 weeks of treatment, 8 weeks and 12 weeks of treatment|Improvement in lipid profile, Improvement in lipid profile from baseline to 8 weeks and to 12 weeks of treatment, including: fasting plasma HDL-cholesterol, fasting plasma triglyceride, 15-minute post prandial plasma triglyceride, and 2-hour post prandial plasma triglyceride, 8 weeks and 12 weeks of treatment|Change in adiponectin, Change in adiponectin from baseline to 8 weeks and to 12 weeks of treatment, 8 weeks and 12 weeks of treatment|Change in waist-to-hip ratio, Change in waist-to-hip ratio from baseline to each of study visit (4 weeks, 8 weeks, and 12 weeks of treatment), 4 weeks, 8 weeks, and 12 weeks of treatment|ECG, ECG will be evaluated at baseline and at end of study (12 weeks of treatment), 12 weeks of treatment|Vital signs, Vital signs (systolic and diastolic blood pressure, heart rate, respiration rate) will be evaluated at baseline and at each study visit (4 weeks, 8 weeks, and 12 weeks of treatment), 4 weeks, 8 weeks, and 12 weeks of treatment|Body weight, Body weight will be evaluated at baseline and at each study visit (4 weeks, 8 weeks, and 12 weeks of treatment), 4 weeks, 8 weeks, and 12 weeks of treatment|Liver function, Liver function (levels of serum ALT, γ-GT, alkaline phosphatase) will be evaluated at baseline and at end of study (12 weeks of treatment), 12 weeks of treatment|Renal function, Renal function (serum creatinine level) will be evaluated at baseline and at end of study (12 weeks of treatment), 12 weeks of treatment|Adverse events, Adverse events as well as number of subjects experienced the events will be observed and evaluated during study period (12 weeks) and until all adverse events have been recovered or stabilized, 1-12 weeks of treatment
Sponsor/Collaborators: Sponsor: Dexa Medica Group
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2011-11
Completion Date: 2012-07
Results First Posted:
Last Update Posted: 2012-08-07
Locations: Department of Internal Medicine, dr. M. Djamil Padang Hospital, Padang, West Sumatera, Indonesia
URL: https://clinicaltrials.gov/show/NCT01531933