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RECRUITINGPhase 1INTERVENTIONAL

Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics

Phase 1 Dose Escalating Study for Montbretin a

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

Montbretin A

The investigational product is 95% pure montbretin A (MbA), a glycosylated acyl-flavonol isolated from the corms (bulbs) of the Crocosmia plant through hot water extraction. It is a potent and specific inhibitor of human pancreatic amylase (HPA).

Locations (1)

VCHRI Clinical Research Unit
Vancouver, British Columbia, Canada