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Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

NCT01005069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2010-09-28

No results posted yet for this study

Summary

The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

DLBS-32

DLBS-32 50 mg once daily and lifestyle modification

DRUG

DLBS-32

DLBS-32 100 mg once daily and lifestyle modification

DRUG

DLBS-32

DLBS-32 200 mg once daily and lifestyle modification

DRUG

DLBS-32

DLBS-32 300 mg once daily and lifestyle modification

DRUG

Placebo capsule

Placebo capsules once daily and lifestyle modification

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Ketut Suastika, Prof. Dr. · Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar Hospital

  • Nuniek E Nugrahini, Dr. · Department of internal medicine, RSUD Tarakan

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
2009-10-31
Primary Completion
2010-07-31
Completion
2010-08-31

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 NCT01005069 on ClinicalTrials.gov