What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include oral antihyperglycemic agents, GLP-1 receptor agonists, SGLT2 inhibitors, and alpha-glucosidase inhibitors. Oral antihyperglycemic agents like metformin can cause gastrointestinal issues such as nausea and diarrhea. GLP-1 receptor agonists, such as liraglutide, may lead to nausea, vomiting, and potential pancreatitis. SGLT2 inhibitors, like dapagliflozin, can cause urinary tract infections and genital infections. Alpha-glucosidase inhibitors, such as acarbose, often result in gastrointestinal side effects like flatulence and diarrhea. These side effects highlight the need for treatments with fewer adverse effects, such as the investigational Montbretin A.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Type 2 Diabetes that aim to improve glycemic control with a focus on minimizing side effects. Notable among these are GLP-1 receptor agonists such as liraglutide and semaglutide, which have shown benefits in glycemic control and weight loss. Additionally, SGLT2 inhibitors like dapagliflozin have been approved, demonstrating efficacy in lowering blood glucose levels with a favorable safety profile. These treatments are similar to the investigational product Montbretin A (MbA), which is being studied for its potential to treat Type 2 Diabetes with fewer side effects.

What other types of research exist?

Promising novel alternatives to Montbretin A (MbA) for treating type 2 diabetes in 2024 include SGLT-2 inhibitors (e.g., empagliflozin, dapagliflozin), GLP-1 agonists (e.g., semaglutide, dulaglutide), and imeglimin. These medications have shown good tolerance and efficacy in clinical trials, with relatively few adverse effects.

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Dietary Supplement

Montbretin A 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

No Placebo-Only Group

Summary

This trial tests Montbretin A (MbA) in people with type 2 diabetes to see if it is safe and has fewer side effects than current treatments. MbA aims to control blood sugar by blocking a specific process in the body, reducing sugar absorption and sudden increases in blood sugar levels. Participants will take increasing doses of MbA over a short period and undergo various tests to monitor its 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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

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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.