Efficacy and Safety of DLBS3233 in Prediabetic Patients

NCT ID: NCT01531933

Last Updated: 2012-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Prediabetic

Keywords

Prediabetic; Primary prevention; Type 2 diabetes mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

DLBS3233

Group Type: EXPERIMENTAL

DLBS3233

Intervention Type: DRUG

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 DLBS3233

Group Type: PLACEBO_COMPARATOR

Placebo of DLBS3233

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo of DLBS3233

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.

Intervention Type: DRUG

Other Intervention Names

Inlacin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asman Manaf, Prof., Dr., dr., SpPD-KEMD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Padang, West Sumatera, Indonesia

Countries

Indonesia

Other Identifiers

DLBS3233-0711

Identifier Type: -

Identifier Source: org_study_id