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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks
Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks
Hanoi Hospital of Traditional Medical
Hanoi, Vietnam
National Hospital of Traditional Medicine
Hanoi, Vietnam
Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)
Hemoglobin A1c
Time frame: 12 weeks
Change from Baseline at Week 12 in Fasting Plasma Glucose
Fasting Plasma Glucose
Time frame: 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.
Time frame: 12 weeks
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