Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Randomized, Parallel-controlled Study to Evaluate the Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: DIDALA hard capsules
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older at the time of enrollment in the study. Diagnosed with type 2 diabetes according to the Guidelines for the diagnosis of type 2 diabetes of the Ministry of Health (2011). Fasting blood glucose ≤ 10.0 mmol/L. No previous treatment with metformin or other antidiabetic drugs. Ability and willingness to provide written informed consent and comply with the protocol's requirements. Subject who, in the judgment of the Investigator, is likely to be compliant or cooperative during the study. Exclusion Criteria: The patient has been diagnosed with diabetes and has been previously treated with metformin or other antidiabetic agents. Patients with indications for insulin therapy or combination therapy of two or more drugs according to the guidelines for diagnosis and treatment of type 2 diabetes of the Ministry of Health. Pregnancy or lactation. Patients with contraindications to Metformin include severe liver and/or kidney disease, congestive heart failure, cardiovascular collapse, acute myocardial infarction, severe infection, and sepsis. Patients with conditions and circumstances that, in the investigator's opinion, are difficult to ensure adherence to study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIDALA<br>DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam. | Drug: DIDALA hard capsules<br>* DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks<br>|
| Active Comparator: METFORMIN<br> | Drug: Metformin<br>* Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c) | Hemoglobin A1c | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | 12 weeks |