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

• Status: Completed
• Trial end date: 2019-02-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University

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