Efficacy and Safety of DLBS3233 in Prediabetic Patients

NCT01531933 | Completed Phase 3

• 1 other identifier: DLBS3233-0711
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic

Keywords

Prediabetic; Primary prevention; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change in 15-minute post prandial insulin level

  8 weeks of treatment

• Change in 2-hour post prandial insulin level

  8 weeks and 12 weeks of treatment

• Change in 15-minute post prandial plasma glucose

  8 weeks and 12 weeks of treatment

• Change in 2-hour post prandial plasma glucose

  4 weeks, 8 weeks, and 12 weeks of treatment

• Change in HOMA-IR

  8 weeks and 12 weeks of treatment

Study Arms (2)

DLBS3233

EXPERIMENTAL

Drug: DLBS3233

Placebo of DLBS3233

PLACEBO COMPARATOR

Drug: Placebo of DLBS3233

Interventions

DLBS3233 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.

Also known as: Inlacin

DLBS3233

Placebo of DLBS3233 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.

Placebo of DLBS3233

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

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

Padang, West Sumatera, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

DLBS3233

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

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

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 13, 2012
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

ID (1)