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Register:	ClinicalTrials.gov
Last refreshed on:	21 June 2021
Main ID:	NCT04930679
Date of registration:	11/06/2021
Prospective Registration:	No
Primary sponsor:	Centre of Clinical Pharmacology, Hanoi Medical University
Public title:	Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.
Scientific title:	A Phase I, Open-label Safety Evaluation of Andiabet of Traphaco J.S.C on Diabetes Mellitus Type II
Date of first enrolment:	November 24, 2018
Target sample size:	14
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT04930679
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 1

Countries of recruitment
Vietnam

Contacts

Name:	Dung C Nguyen, MD
Address:
Telephone:
Email:
Affiliation:	Center of Clinical Pharmacology, Hanoi Medical University

Key inclusion & 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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Andiabet

Primary Outcome(s)

Adverse events [Time Frame: 28 days]

Fasting blood glucose [Time Frame: 28 days]

Secondary Outcome(s)

Secondary ID(s)

TNLS/2018-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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