Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGDIDALA hard capsules
DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks
DRUGMetformin
Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks
Sponsors
Centre of Clinical Pharmacology, Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c) | 12 weeks | Hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline at Week 12 in Fasting Plasma Glucose | 12 weeks | Fasting Plasma Glucose |
| Safety assessments | 12 weeks | 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. |
Countries
Vietnam
Contacts
Primary ContactCentre of Clinical Pharmacology
Outcome results
None listed