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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLBS3233 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLBS3233 | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of A1c level | Reduction of A1c level from baseline after 12 weeks of treatment | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Askandar Tjokroprawiro, Prof.Dr.dr,SpPD-KEMD,FINASIM | Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Clinic at Jl. Prof. Dr. Moestopo 164 | Surabaya | East Java | Indonesia | |||
| Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital |
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| ID | Term |
|---|---|
| C000613148 | DLBS3233 |
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| 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 |
| Surabaya |
| East Java |
| Indonesia |