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

Primary Purpose

Type-2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
DLBS3233
Sponsored by
Dexa Medica Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type-2 Diabetes Mellitus focused on measuring Type-2 diabetes mellitus, Add-on therapy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private Clinic at Jl. Prof. Dr. Moestopo 164
  • Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DLBS3233

Arm Description

Outcomes

Primary Outcome Measures

Reduction of A1c level
Reduction of A1c level from baseline after 12 weeks of treatment

Secondary Outcome Measures

Reduction of venous A1c level
Reduction of venous A1c level from baseline to 6 weeks of treatment
Reduction of venous FPG
Reduction of venous FPG from baseline to every evaluation-time point
Reduction of venous 1h-PG
Reduction of venous 1 hour-post prandial plasma glucose from baseline to every evaluation-time point
Change in fasting insulin level
Change in fasting insulin level from baseline to every evaluation-time point
Change in HOMA-R
Change in HOMA-R from baseline to every evaluation-time point
Change in HOMA-B
Change in HOMA-B from baseline to every evaluation-time point
Change in adiponectin level
Change in adiponectin level from baseline to every evaluation-time point
Change in lipid profile
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
Change in body weight from baseline to every evaluation-time point
Hematology
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
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
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
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.

Full Information

First Posted
November 11, 2011
Last Updated
May 24, 2013
Sponsor
Dexa Medica Group
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1. Study Identification

Unique Protocol Identification Number
NCT01472614
Brief Title
Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus
Official Title
Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type-2 Diabetes Mellitus
Keywords
Type-2 diabetes mellitus, Add-on therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLBS3233
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DLBS3233
Other Intervention Name(s)
Inlacin
Intervention Description
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)
Primary Outcome Measure Information:
Title
Reduction of A1c level
Description
Reduction of A1c level from baseline after 12 weeks of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction of venous A1c level
Description
Reduction of venous A1c level from baseline to 6 weeks of treatment
Time Frame
6 weeks
Title
Reduction of venous FPG
Description
Reduction of venous FPG from baseline to every evaluation-time point
Time Frame
6 and 12 weeks
Title
Reduction of venous 1h-PG
Description
Reduction of venous 1 hour-post prandial plasma glucose from baseline to every evaluation-time point
Time Frame
6 and 12 weeks
Title
Change in fasting insulin level
Description
Change in fasting insulin level from baseline to every evaluation-time point
Time Frame
6 and 12 weeks
Title
Change in HOMA-R
Description
Change in HOMA-R from baseline to every evaluation-time point
Time Frame
6 and 12 weeks
Title
Change in HOMA-B
Description
Change in HOMA-B from baseline to every evaluation-time point
Time Frame
6 and 12 weeks
Title
Change in adiponectin level
Description
Change in adiponectin level from baseline to every evaluation-time point
Time Frame
6 and 12 weeks
Title
Change in lipid profile
Description
Change in lipid profile from baseline to every evaluation-time point, including: LDL-cholesterol (direct), HDL-cholesterol, total cholesterol, and triglycerides
Time Frame
6 and 12 weeks
Title
Change in body weight
Description
Change in body weight from baseline to every evaluation-time point
Time Frame
6 and 12 weeks
Title
Hematology
Description
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
Time Frame
6 and 12 weeks
Title
Liver function
Description
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
Time Frame
6 and 12 weeks
Title
Renal function
Description
Renal function parameter, i.e. serum creatinine level will be measured at baseline, at interval of 6 weeks, and at the end of study
Time Frame
6 and 12 weeks
Title
Adverse events
Description
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.
Time Frame
1-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Askandar Tjokroprawiro, Prof.Dr.dr,SpPD-KEMD,FINASIM
Organizational Affiliation
Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Clinic at Jl. Prof. Dr. Moestopo 164
City
Surabaya
State/Province
East Java
Country
Indonesia
Facility Name
Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital
City
Surabaya
State/Province
East Java
Country
Indonesia

12. IPD Sharing Statement

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

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