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

Centre of Clinical Pharmacology, Hanoi Medical University

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Andiabet

Study type

Interventional

Funder types

Other

Identifiers

NCT04930679

TNLS/2018-03

Details and patient eligibility

About

This phase I clinical trial is used to evaluate the safety of Andiabet, a herbal-derived medicinal product that assists in the treatment of type 2 Diabetes (T2D). Thereby, determine efficacy of the drug on stabilizing blood glucose in T2D patients.

Full description

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.

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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