Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics

NCT05826054 | Recruiting Phase 1

• 1 other identifier: MbA01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Montbretin A; Type II Diabetes Mellitus Without Complication; Noninsulin-Dependent Diabetes Mellitus; Healthy participants

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  The MTD is defined as the minimum dose that results in a dose limiting toxicity in the form of gastro-intestinal adverse events (relevant flatulence and/or diarrhea as determined by the Gastrointestinal Symptom Rating Scale) in 33% of the test subjects.

  2 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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).

Dietary Supplement: Montbretin A

Interventions

Montbretin A DIETARY_SUPPLEMENT

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).

Intervention

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Petrella: lead
• Michael Smith Foundation for Health Research: collaborator
• Canadian Glycomics Network (GlycoNet) - Networks of Centres of Excellence (NCE): collaborator

Study Sites (1)

VCHRI Clinical Research Unit

Vancouver, British Columbia, V5Y2S7, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

montbretin A

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Robert Petrella, MD, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Storms

CONTACT

604-875-5886; michelle.storms@vch.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Head (Chair), Department of Family Practice

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: December 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)