Clinical trial NCT04930679: Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.
Official title: A Phase I, Open-label Safety Evaluation of Andiabet of Traphaco J.S.C on Diabetes Mellitus Type II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Centre of Clinical Pharmacology, Hanoi Medical University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 diabetes type 2 patients are recruited, in which 14 took part in the study, randomly divided into 2 arms.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Adverse events
timeFrame: 28 days
measure: Fasting blood glucose
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Centre of Clinical Pharmacology, Hanoi Medical University
Study officials:
affiliation: Center of Clinical Pharmacology, Hanoi Medical University
name: Dung C Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: