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Dietary Supplement

Intervention for Type 2 Diabetes (MbA Trial)

Phase 1
Recruiting
Led By Robert Petrella, MD, PhD
Research Sponsored by Robert Petrella
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Summary

This trial will assess the safety of montbretin A for Type 2 Diabetes sufferers: establishing a safe dosage range and any potential side effects.

Who is the study for?
This trial is for adults with type 2 diabetes who manage their condition through diet alone, have normal blood values, and eat three meals a day. Participants must use effective birth control or be sterile/menopausal. They should understand the study's schedule and medication dosing.Check my eligibility
What is being tested?
The Montbretin A (MbA) clinical trial tests the safety of MbA in treating type 2 diabetes and if it has fewer side effects compared to existing treatments. Patients will take increasing doses of MbA over two weeks alongside standardized meals.See study design
What are the potential side effects?
Potential side effects are not specified but will be monitored through various tests such as blood draws, sugar checks, ECGs, breath testing, and questionnaires to assess any adverse reactions from Montbretin A.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 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).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 2 Diabetes (T2DM) work through various mechanisms to control blood glucose levels. Metformin reduces hepatic glucose production and improves insulin sensitivity. Sulfonylureas stimulate insulin secretion from pancreatic beta cells. GLP-1 receptor agonists, like liraglutide, enhance glucose-dependent insulin secretion and slow gastric emptying, which can aid in weight loss. DPP-4 inhibitors prevent the breakdown of incretin hormones, thereby increasing insulin release and decreasing glucagon levels. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion in urine. Insulin therapy directly supplements insulin levels. The investigational product Montbretin A (MbA) aims to treat T2DM potentially with fewer side effects, which is crucial for improving patient adherence and reducing the risk of complications associated with current treatments.
Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline.Current Strategies and Drug Targets in the Management of Type 2 Diabetes Mellitus.Cardiovascular safety of type 2 diabetes medications: Review of existing literature and clinical implications.

Find a Location

Who is running the clinical trial?

Robert PetrellaLead Sponsor
Michael Smith Foundation for Health ResearchOTHER
19 Previous Clinical Trials
6,065 Total Patients Enrolled
Canadian Glycomics Network (GlycoNet) - Networks of Centres of Excellence (NCE)UNKNOWN

Media Library

Montbretin A (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05826054 — Phase 1
Type 2 Diabetes Research Study Groups: Intervention
Type 2 Diabetes Clinical Trial 2023: Montbretin A Highlights & Side Effects. Trial Name: NCT05826054 — Phase 1
Montbretin A (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05826054 — Phase 1
~16 spots leftby Jul 2025