A Phase 3 interventional study of DLBS3233 and Placebo of DLBS3233 in Prediabetic, sponsored by Dexa Medica Group. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by Dexa Medica Group · Phase 3, Interventional, and Prevention
This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233.
It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first phase) insulin secretion as well as insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes into type 2 diabetes mellitus.
There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 for 12 weeks of therapy.
Subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. All subjects will be advised to follow such a lifestyle modification throughout the study period.
All subjects will be under direct supervision of a medical doctor during the study period.
All clinical and laboratory examinations to evaluate the investigational drug's efficacy, will be performed at baseline, Week 8th and Week 12th (end) of study treatment. Blood glucose level (both FPG and 2h-PG) will be performed at baseline and at interval of 4 weeks over the 12 weeks of study treatment. Safety examinations will be performed at baseline and at the end of study. Occurrence of adverse event will be observed during the study.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 80 is close to the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Dexa Medica Group is the lead sponsor of 41 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: DLBS3233
Drug: Placebo of DLBS3233
For the first 4 weeks, subjects should take DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of \< 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.
Also known as: Inlacin
For the first 4 weeks, subjects should take placebo of DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of \< 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.
Change in 15-minute post prandial insulin level
Change in 15-minute post prandial insulin level from baseline to 12 weeks of treatment
Time frame: 12 weeks of treatment
Change in 15-minute post prandial insulin level
Change in 15-minute post prandial insulin level from baseline to 8 weeks of treatment
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks and 12 weeks of treatment
Change in adiponectin
Change in adiponectin from baseline to 8 weeks and to 12 weeks of treatment
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 1-12 weeks of treatment
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: DLBS3233