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Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus

NCT01645332 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2014-10-08

No results posted yet for this study

Summary

This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

Conditions

  • Type-2-diabetes Mellitus
  • New Onset

Interventions

DRUG

Placebo of DLBS3233

Placebo of DLBS3233 once daily for 12 weeks

DRUG

DLBS3233

100 mg DLBS3233 once daily for 12 weeks

OTHER

Lifestyle modification

Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Heri Nugroho, Dr,dr,SpPD,KEMD,FINASIM · Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01645332 on ClinicalTrials.gov