Efficacy and Safety of DLBS3233 in Prediabetic Patients

Phase 3CompletedNCT01531933

Dexa Medica Group80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Prediabetic

Interventions

DLBS3233DRUG

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.

Placebo of DLBS3233DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects with age of 18-60 years * Prediabetic patients (2h-PPPG level of 140-199 mg/dL) * Serum ALT ≤ 2.5 times upper limit of normal * Serum creatinine \< 1.5 times upper limit of normal * Able to take oral medication Exclusion Criteria: * Female of childbearing potential * History of diabetes mellitus * History of symptomatic coronary arterial disease, stroke, and cardiovascular events * Current treatment with systemic corticosteroids or herbal (alternative) medicines * Any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation * Participation in any other clinical studies within 30 days prior to screening

Locations (1)

Department of Internal Medicine, dr. M. Djamil Padang Hospital

Padang, West Sumatera, Indonesia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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