Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.

This is a 28-day phase I, open-label clinical trial to evaluate safety of Andiabet on . The general purpose is the evaluate safety via adverse events and tolerability of Andiabet on T2D patients, and evaluate effect of Andiabet on clinical and laboratory parameters.

The study conducted on volunteering T2D patients, whose HbA1c level is =< 7.5% and are not pregnant, had no records of addiction, allergy, hypersensitivity, and chronic diseases. The main evaluation criteria are fasting glucose, used for evaluating efficacy and safety, which evaluated based on adverse events.

Ensuring quality of the data:

Sponsor and CRO are supervisors. Supervision will be conducted periodically, ensuring the compliance with the research proposal, following GCP.

Hanoi Medical University-Clinical center of Pharmacology is responsible for managing the data. Completed CFR are sent to the Center of Clinical Pharmacology, entered by Microsoft Excel and analysed using SPSS 16.0 Before analysing, these data will be checked randomly, avoiding errors in data entry.

Inclusion criteria

Participants must meet ALL the following criteria:

• Type 2 Diabetes (T2D) patients with HbA1c lower than or equal to 7.5%
• BMI range: 18-40 kg/m2
• Diagnosed with T2D or currently treating T2D (prescribed by physicians) with one or more of the following drugs: Metformin, Sulfonyl urea, dipeptidyl peptidase-4 inhibitors, or a-glucosidase inhibitors
• Be able to stop using T2D drugs in 4 weeks, while maintaining diets and exercising routine.
• Willing to take part in the study.

Exclusion criteria

Participants that have ONE of the following:

• Diagnosed with Type 1 Diabetes.
• History of complications due to Diabetes Mellitus.
• History of cardiovascular diseases: hypertension, heart failure, Unstable agina, stroke or transient ischemic attack, myocardial infarction, arrhythmias, coronary artery interventions.
• History of drugs, alcohol addiction.
• Uncontrolled high blood pressure
• Pre-study screening blood test with abnormal results in total blood compositions, urea, AST, ALT, creatinine, albumin, total bilirubin, total urine analysis.
• Test positive for HIV or HbsAg
• Abnormal ECG results that are clinically significant.
• History of hypersensitivity to any of the ingredients in the testing product.
• Female participants that are pregnant or having pregnancy intention