Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics
Recruiting · NCT05826054 · Interventional (participants receive a specific treatment) · Lead sponsor: Robert Petrella
View the official record on ClinicalTrials.gov →Interventions studied
Montbretin A
What this trial is about
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 take part
Age range
19 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- VCHRI Clinical Research Unit - Vancouver, British Columbia, Canada