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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01472614
First received: November 11, 2011
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Type-2 Diabetes Mellitus
Drug: DLBS3233
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:
  • Reduction of A1c level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Reduction of A1c level from baseline after 12 weeks of treatment


Secondary Outcome Measures:
  • Reduction of venous A1c level [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Reduction of venous A1c level from baseline to 6 weeks of treatment

  • Reduction of venous FPG [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Reduction of venous FPG from baseline to every evaluation-time point

  • Reduction of venous 1h-PG [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Reduction of venous 1 hour-post prandial plasma glucose from baseline to every evaluation-time point

  • Change in fasting insulin level [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Change in fasting insulin level from baseline to every evaluation-time point

  • Change in HOMA-R [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Change in HOMA-R from baseline to every evaluation-time point

  • Change in HOMA-B [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Change in HOMA-B from baseline to every evaluation-time point

  • Change in adiponectin level [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Change in adiponectin level from baseline to every evaluation-time point

  • Change in lipid profile [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Change in lipid profile from baseline to every evaluation-time point, including: LDL-cholesterol (direct), HDL-cholesterol, total cholesterol, and triglycerides

  • Change in body weight [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Change in body weight from baseline to every evaluation-time point

  • Hematology [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: Yes ]
    Hematology parameters (Hemoglobin level, Hematocrit, Red Blood Cell count, White Blood Cell count as well as its differentials, and platelet count) will be evaluated at baseline, at interval of 6 weeks, and at the end of study

  • Liver function [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: Yes ]
    Liver function parameters (serum ALT, serum AST, gamma-glutamyl transferase, alkaline phosphatase, and total bilirubin levels) will be measured at baseline, at interval of 6 weeks, and at the end of study

  • Renal function [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: Yes ]
    Renal function parameter, i.e. serum creatinine level will be measured at baseline, at interval of 6 weeks, and at the end of study

  • Adverse events [ Time Frame: 1-12 weeks ] [ Designated as safety issue: Yes ]
    Adverse events as well as number of subjects experienced the events will be observed and evaluated during the study period (12 weeks) and until all adverse events have been recovered or stabilized.


Enrollment: 54
Study Start Date: September 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DLBS3233 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)
Other Name: Inlacin

Detailed Description:

There will only be one group in this study who will receive study treatment as follows: anti-diabetic agents currently used by respective subjects for at least 3 months prior to Screening, treatment intensification (lifestyle modification), and DLBS3233 at a dose of 100 mg once daily for 12 weeks.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at interval of 6 weeks over the 12-week course of therapy.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects with age of 40 - 70 years; or female subjects with age of 55 - 70 years (post-menopause) at screening
  • Diagnosed with type-2 diabetes mellitus
  • Have been being treated with a combination of two OHA for at least 3 months prior to screening
  • A1c level of >= 7.0 %
  • Hemoglobin level of >= 10 g/dL
  • Body Mass Index (BMI) > 18.5 kg/m2
  • Refuse insulin therapy
  • Able to take oral medicine

Exclusion Criteria:

  • Subjects with symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
  • History of or current chronic treatment with insulin
  • History of renal and/or liver disease
  • Impaired liver function: serum ALT > 2.5 times upper limit of normal and positive result of chronic or acute hepatitis B or C test
  • Impaired renal function: serum creatinine >= 1.5 times upper limit of normal
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472614

Locations
Indonesia
Private Clinic at Jl. Prof. Dr. Moestopo 164
Surabaya, East Java, Indonesia
Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital
Surabaya, East Java, Indonesia
Sponsors and Collaborators
Dexa Medica Group
Investigators
Principal Investigator: Askandar Tjokroprawiro, Prof.Dr.dr,SpPD-KEMD,FINASIM Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
  More Information

No publications provided

Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01472614     History of Changes
Other Study ID Numbers: DLBS3233-0411
Study First Received: November 11, 2011
Last Updated: May 24, 2013
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
Type-2 diabetes mellitus
Add-on therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014