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

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

• 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.
  
  

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.