Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics (NCT05826054) | Clinical Trial Compass
RecruitingPhase 1
Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics
Canada50 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range19 Years – 65 Years
SexALL
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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 en…