Phase 1 Dose Escalating Study for Montbretin a

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 65
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Canada
VCHRI Clinical Research Unit
RECRUITING
Vancouver
Contact Information
Primary
Michelle Storms
michelle.storms@vch.ca
604-875-5886
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-02
Participants
Target number of participants: 50
Treatments
Experimental: Intervention
In this study, participants will receive increasing dosages of the Study Treatment (Montbretin A, MbA) at each treatment visit. The Study Treatment will be taken with a standardized meal (a meal that has specified quantities of carbohydrates, fats and proteins). At each visit, participants will receive one dose (in pill form) of MbA. As long as they are not experiencing any side effects, this dose will be gradually increased at each study visit (starting from 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, to 300 mg MbA).
Related Therapeutic Areas
Sponsors
Leads: Robert Petrella
Collaborators: Michael Smith Foundation for Health Research, Canadian Glycomics Network (GlycoNet) - Networks of Centres of Excellence (NCE)

This content was sourced from clinicaltrials.gov