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

• Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04930679
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Andiabet	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 20 diabetes type 2 patients are recruited, in which 14 took part in the study, randomly divided into 2 arms.20 diabetes type 2 patients are recruited, in which 14 took part in the study, randomly divided into 2 arms.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I, Open-label Safety Evaluation of Andiabet of Traphaco J.S.C on Diabetes Mellitus Type II
• Actual Study Start Date: Nov 24, 2018
• Actual Primary Completion Date: Feb 22, 2019
• Actual Study Completion Date: Feb 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I 1 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days	Drug: Andiabet; Each hard capsule includes: 200mg Gynostemma Pentaphyllum Leaf, 200mg Largerstroemia Speciosa Leaf, 133mg Anemarrhena Asphodeloides Whole
Experimental: Group II 2 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days	Drug: Andiabet; Each hard capsule includes: 200mg Gynostemma Pentaphyllum Leaf, 200mg Largerstroemia Speciosa Leaf, 133mg Anemarrhena Asphodeloides Whole

Outcome Measures

Primary Outcome Measures

1. Adverse events [28 days]

   2 AEs recorded, there were changes in biochemical indices. However, these AEs are considered mild and unrelated to the investigated product.

2. Fasting blood glucose [28 days]

   Group II is reported to have lower blood glucose compared to group I. However, the difference is efficacy is not clear between 2 groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Clinical Pharmacology, Hanoi Medical University	Hanoi		Vietnam

Sponsors and Collaborators

• Centre of Clinical Pharmacology, Hanoi Medical University

Investigators

• Principal Investigator: Dung C Nguyen, MD, Center of Clinical Pharmacology, Hanoi Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre of Clinical Pharmacology, Hanoi Medical University
• ClinicalTrials.gov Identifier: NCT04930679
• Other Study ID Numbers: TNLS/2018-03
• First Posted: Jun 18, 2021
• Last Update Posted: Jun 18, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 18, 2021