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Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus

NCT01472614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-05-27

No results posted yet for this study

Summary

This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.

Conditions

  • Type-2 Diabetes Mellitus

Interventions

DRUG

DLBS3233

Study treatment will be DLBS3233 at a dose of 100 mg once daily (for 12 weeks) in addition to current anti-diabetic treatment used by respective study subjects and treatment intensification (lifestyle modification)

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Askandar Tjokroprawiro, Prof.Dr.dr,SpPD-KEMD,FINASIM · Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-01-31
Completion
2013-04-30

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 NCT01472614 on ClinicalTrials.gov