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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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)
Private Clinic at Jl. Prof. Dr. Moestopo 164
Surabaya, East Java, Indonesia
Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital
Surabaya, East Java, Indonesia
Reduction of A1c level
Reduction of A1c level from baseline after 12 weeks of treatment
Time frame: 12 weeks
Reduction of venous A1c level
Reduction of venous A1c level from baseline to 6 weeks of treatment
Time frame: 6 weeks
Reduction of venous FPG
Reduction of venous FPG from baseline to every evaluation-time point
Time frame: 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
Time frame: 6 and 12 weeks
Change in fasting insulin level
Change in fasting insulin level from baseline to every evaluation-time point
Time frame: 6 and 12 weeks
Change in HOMA-R
Change in HOMA-R from baseline to every evaluation-time point
Time frame: 6 and 12 weeks
Change in HOMA-B
Change in HOMA-B from baseline to every evaluation-time point
Time frame: 6 and 12 weeks
Change in adiponectin level
Change in adiponectin level from baseline to every evaluation-time point
Time frame: 6 and 12 weeks
Change in lipid profile
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Change in body weight
Change in body weight from baseline to every evaluation-time point
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 1-12 weeks