Testing Montbretin A in Healthy Volunteers and People with Type 2 Diabetes
Phase 1 Dose Escalating Study for Montbretin a
This study is testing if a new drug called Montbretin A can safely help manage blood sugar levels in people with type 2 diabetes and healthy volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05826054 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and side effects of Montbretin A (MbA) in individuals with type 2 diabetes and healthy participants. Over a two-week period, participants will receive increasing doses of MbA, ranging from 10 mg to 300 mg, alongside standardized meals. The study will include various assessments such as blood draws, blood sugar checks, electrocardiograms (ECGs), and questionnaires to monitor the effects of the treatment. The goal is to determine if MbA can effectively manage blood sugar levels with fewer side effects compared to existing diabetes medications.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 to 65 with diagnosed type 2 diabetes managed by diet alone or healthy volunteers without diabetes.
Not a fit: Patients with type 2 diabetes requiring medication beyond dietary management or those with significant health complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for managing blood sugar levels in patients with type 2 diabetes with fewer side effects.
How similar studies have performed: While there have been studies on alpha-glucosidase inhibitors, the specific approach with Montbretin A is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vancouver, British Columbia
- VCHRI Clinical Research Unit — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Robert Petrella, MD, PhD — University of British Columbia
- Study coordinator: Michelle Storms
- Email: michelle.storms@vch.ca
- Phone: 604-875-5886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.