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

Study Overview
=================
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.

Official Title
-----------------
Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus

Conditions
-----------------
Type-2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: DLBS3233


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DLBS3233<br> | Drug: DLBS3233<br>* 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)<br>* Other names: Inlacin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of A1c level | Reduction of A1c level from baseline after 12 weeks of treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of venous A1c level | Reduction of venous A1c level from baseline to 6 weeks of treatment | 6 weeks | 
| Reduction of venous FPG | Reduction of venous FPG from baseline to every evaluation-time point | 6 and 12 weeks | 
| Reduction of venous 1h-PG | Reduction of venous 1 hour-post prandial plasma glucose from baseline to every evaluation-time point | 6 and 12 weeks | 
| Change in fasting insulin level | Change in fasting insulin level from baseline to every evaluation-time point | 6 and 12 weeks | 
| Change in HOMA-R | Change in HOMA-R from baseline to every evaluation-time point | 6 and 12 weeks | 
| Change in HOMA-B | Change in HOMA-B from baseline to every evaluation-time point | 6 and 12 weeks | 
| Change in adiponectin level | Change in adiponectin level from baseline to every evaluation-time point | 6 and 12 weeks | 
| 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 | 6 and 12 weeks | 
| Change in body weight | Change in body weight from baseline to every evaluation-time point | 6 and 12 weeks | 
| 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 | 6 and 12 weeks | 
| 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 | 6 and 12 weeks | 
| 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 | 6 and 12 weeks | 
| 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. | 1-12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type-2 diabetes mellitus, Add-on therapy