Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics

Summary

The goal of this clinical trial is to test the investigational product, Montbretin A (MbA) in either individuals with type 2 diabetes (T2D) or healthy participants. The main questions it aims to answer are: * Safety of MbA * Whether MbA has less side effects in comparison to other medications used to treat T2D Participants will: * Be given MbA at increasing amounts (10 mg to 300 mg) over a two-week treatment period, along with standardized meal; * Undergo testing, including blood draws, blood sugar checks, electrocardiogram (ECG) and questionnaires.

Eligibility

Inclusion Criteria:

* Male or female, age ≤ 65 years; ≥19 years;
* Have diagnosed type-2 diabetes mellitus with HbA1C between 6.5% to 11% that is currently managed by diet and no other medications or healthy volunteers defined as not having diagnosis of type-2 diabetes mellitus.
* Have routine and normal dietary habits that include three meals a day;
* Normal hematological parameters as determined through an in-person screening blood draw including HbA1C \>4.0% in healthy volunteers.
* Use of an effective barrier method of birth control throughout the study, surgical sterility, or menopausal for at least 2 years;
* In the study team's opinion, capable of understanding the visit schedule requirement and study medication dosing requirements.
* Be able to avoid all supplements that affect blood sugar for the duration of the study eg. chromium, bitter melon, thiamine, berberine, alpha-lipoic acid, devil's claw, horse chestnut, fenugreek, ginseng, psyllium, cinnamon, garlic and panax.

Exclusion Criteria:

* Currently in poor health, as determined by the study doctor
* Currently on medication, except vitamins and/or birth control
* Not eating three regular meals a day
* Current or a history of impairment of gastro-intestinal function, including but not limited to inflammatory bowel disease, colonic ulceration, and/or partial intestinal obstruction
* Travelled to a foreign country less than four (4) weeks prior to study entry;
* Surgery less than four (4) weeks a prior to study entry;
* Pregnant or lactating women;
* Planning to participate in other investigational drugs while participating in the study;
* Known allergy to study medication or its components (non-medicinal ingredients); and
* A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits

Conditions2

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