Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, two-group parallel study, comparing before and after treatment within the same group and between the two groups. This study is designed to collect data on the safety and efficacy of a marketed pharmaceutical product (DIDALA) compared with Metformin. The efficacy data of DIDALA will be directly compared with Metformin 1000mg/day monotherapy in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIDALA | Experimental | DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam. |
|
| METFORMIN | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIDALA hard capsules | Drug | DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c) | Hemoglobin A1c | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline at Week 12 in Fasting Plasma Glucose | Fasting Plasma Glucose | 12 weeks |
| Safety assessments | Safety will be assessed based on the frequency of occurrence of adverse events (AEs) of concern including hypoglycaemic events, clinically significant changes in laboratory parameters (complete blood count, blood biochemistry test), and vital signs during the study period. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Centre of Clinical Pharmacology | Contact | +84 24 3852 3798 | 3188 | duoclylamsang@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Hospital of Traditional Medical | Hanoi | Vietnam |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metformin | Drug | Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks |
|
| 12 weeks |
| National Hospital of Traditional Medicine | Hanoi | Vietnam |
|
| D004700 | Endocrine System Diseases |