Back to resultsEvaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
Andiabet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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
Sites / Locations
- Centre of Clinical Pharmacology, Hanoi Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I
Group II
Arm Description
1 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days
2 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days
Outcomes
Primary Outcome Measures
Adverse events
2 AEs recorded, there were changes in biochemical indices. However, these AEs are considered mild and unrelated to the investigated product.
Fasting blood glucose
Group II is reported to have lower blood glucose compared to group I. However, the difference is efficacy is not clear between 2 groups
Secondary Outcome Measures
Full Information
NCT ID
NCT04930679
First Posted
June 11, 2021
Last Updated
June 11, 2021
Sponsor
Centre of Clinical Pharmacology, Hanoi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04930679
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 24, 2018 (Actual)
Primary Completion Date
February 22, 2019 (Actual)
Study Completion Date
February 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre of Clinical Pharmacology, Hanoi Medical University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
20 diabetes type 2 patients are recruited, in which 14 took part in the study, randomly divided into 2 arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
1 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days
Arm Title
Group II
Arm Type
Experimental
Arm Description
2 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days
Intervention Type
Drug
Intervention Name(s)
Andiabet
Intervention Description
Each hard capsule includes: 200mg Gynostemma Pentaphyllum Leaf, 200mg Largerstroemia Speciosa Leaf, 133mg Anemarrhena Asphodeloides Whole
Primary Outcome Measure Information:
Title
Adverse events
Description
2 AEs recorded, there were changes in biochemical indices. However, these AEs are considered mild and unrelated to the investigated product.
Time Frame
28 days
Title
Fasting blood glucose
Description
Group II is reported to have lower blood glucose compared to group I. However, the difference is efficacy is not clear between 2 groups
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dung C Nguyen, MD
Organizational Affiliation
Center of Clinical Pharmacology, Hanoi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Clinical Pharmacology, Hanoi Medical University
City
Hanoi
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.
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