Montbretin A for Type 2 Diabetes

(MbA Trial)

Recruiting at1 trial location

Overseen by Robert Petrella, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Robert Petrella

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

Yes, you must stop taking your current medications, except for vitamins and/or birth control, to participate in the trial.

What data supports the idea that Montbretin A for Type 2 Diabetes is an effective treatment?

The available research does not provide specific data on Montbretin A for Type 2 Diabetes. Instead, it discusses various other treatments like incretin-based therapies, which help control blood sugar and may also help with weight management. These therapies are considered promising because they might protect the cells that produce insulin, potentially slowing down the disease. However, there is no mention of Montbretin A in the context of these studies. ^{1 2 3 4 5}

What safety data is available for Montbretin A (MbA) in treating Type 2 Diabetes?

The provided research does not contain specific safety data for Montbretin A (MbA). It discusses safety data for incretin-based therapies and other diabetes treatments, but Montbretin A is not mentioned. Therefore, no direct safety data for Montbretin A is available in the provided research. ^{6 7 8 9 10}

Is Montbretin A a promising drug for Type 2 Diabetes?

Montbretin A could be a promising drug for Type 2 Diabetes because it may help improve blood sugar control, which is important for reducing the risk of diabetes-related complications. ^{1 11 12 13 14}

Research Team

Robert Petrella, MD, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

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.

Inclusion Criteria

I manage my type-2 diabetes with diet alone.

Normal dietary habit that includes three meals a day, as determined by the study doctor

Ability to return for all scheduled study visits

Exclusion Criteria

Traveled to a foreign country less than four (4) weeks prior to study entry

Currently in poor health, as determined by the study doctor

I am taking medication other than vitamins or birth control.

Treatment Details

Interventions

• Montbretin A (Dietary Supplement)

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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).

Montbretin A is already approved in Canada for the following indications:

Approved in Canada as Montbretin A for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Robert Petrella

Lead Sponsor

Trials

1

Recruited

50+

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Dr. Christopher Haqq

University of British Columbia

Chief Medical Officer since 2019

MD, University of British Columbia

Bekki Bracken Brown

University of British Columbia

Chief Executive Officer since 2023

Bachelor's degree from Duke University

Michael Smith Foundation for Health Research

Collaborator

Trials

20

Recruited

6,100+

Canadian Glycomics Network (GlycoNet) - Networks of Centres of Excellence (NCE)

Collaborator

Trials

1

Recruited

50+

Canadian Glycomics Network (GlycoNet)

Collaborator

Trials

2

Recruited

90+

Findings from Research

The U.S. FDA has approved six classes of oral medications for type 2 diabetes, with metformin and lifestyle changes recommended as the first-line treatments according to a consensus by the American Diabetes Association and the European Association for the Study of Diabetes.

New therapies in development, including incretin therapies and agents targeting metabolic syndrome, show promise for improving treatment options for type 2 diabetes, especially for patients struggling with weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes: new and future developments in treatment. Liao, EP.[2022]

Type 2 diabetes is primarily caused by issues with insulin resistance and declining beta-cell function, making it crucial for healthcare providers to understand these mechanisms to tailor effective treatments.

Newer treatments like incretin therapy fill a gap in diabetes management by modulating glucose supply, and combining different antidiabetic agents can significantly enhance glycemic control for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for the treatment of patients with type 2 diabetes mellitus: rationale and specific agents. Cefalu, WT.[2022]

Proactive intensification of insulin therapy in diabetes patients is crucial for minimizing the risks of chronic hypo/hyperglycemia and reducing weight gain while achieving personalized blood sugar targets.

This review provides evidence-based recommendations for physicians on how to effectively intensify insulin therapy and consider GLP-1 analogues for patients with type 2 diabetes who do not respond adequately to basal insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based recommendations for insulin intensification strategies after basal insulin in type 2 diabetes. Ghosh, S., Unnikrishnan, AG., Saboo, B., et al.[2018]

Incretin-based therapies, such as GLP-1 receptor agonists and DPP-4 inhibitors, not only help control blood sugar levels in type 2 diabetes but also have weight-neutral or weight-reducing effects, making them beneficial for patients with obesity-related diabetes.

These therapies may preserve beta-cell function, suggesting they could modify the disease's progression, and early use of GLP-1 receptor agonists may prevent diabetes in at-risk individuals or slow down the disease in those already diagnosed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of incretin-based therapy: therapeutic potential, patient selection and clinical use. Kendall, DM., Cuddihy, RM., Bergenstal, RM.[2022]

Incretin-based therapies, such as GLP-1 receptor agonists and DPP-4 inhibitors, not only help control blood sugar levels in type 2 diabetes but also have weight-neutral or weight-reducing effects, making them beneficial for patients with obesity-related diabetes.

These therapies may preserve beta-cell function, suggesting they could potentially modify the disease progression of type 2 diabetes, and early use might prevent diabetes in at-risk individuals or slow its progression in those already diagnosed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of incretin-based therapy: therapeutic potential, patient selection and clinical use. Kendall, DM., Cuddihy, RM., Bergenstal, RM.[2011]

Incretin-based therapies, such as DPP-4 inhibitors and GLP-1 agonists, provide effective glycemic control for type 2 diabetes patients without the weight gain often seen with traditional treatments, making them a favorable option for many.

Clinical trial data suggest that these therapies are safe, showing no negative effects on cardiovascular health, and their integration into treatment plans can enhance options for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New therapeutic options: management strategies to optimize glycemic control. Freeman, JS.[2022]

Incretin-based therapies, including GLP-1 receptor agonists and DPP-4 inhibitors, effectively lower blood sugar levels in type 2 diabetes while also improving beta-cell function, blood pressure, and lipid levels, with a low risk of causing hypoglycemia.

GLP-1 receptor agonists are associated with weight loss, whereas DPP-4 inhibitors are weight neutral, highlighting important differences in their clinical profiles for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of incretin based therapies: clinical trial data. White, J.[2022]

In a study involving approximately 32,800 users of exenatide, there was a modestly higher incidence of claims for thyroid malignancies compared to users of metformin or glyburide, but this association was not significant when focusing on inpatient claims.

Exenatide use was not linked to an increased risk of benign thyroid neoplasms or pancreatic cancer, suggesting it may be a safe option regarding these specific cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. Dore, DD., Seeger, JD., Chan, KA.[2021]

Alogliptin, a selective dipeptidyl peptidase-4 inhibitor, has shown effectiveness and good tolerability in treating type 2 diabetes in Phase II and III studies, making it a promising option for patients.

This medication can be used alone or in combination with other diabetes treatments like metformin and insulin, and it has an excellent safety profile, addressing some of the limitations of current diabetes therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alogliptin: a novel molecule for improving glycemic control in type II diabetes mellitus. Ghatak, SB., Patel, DS., Shanker, N., et al.[2019]

A meta-analysis of 36 randomized trials involving GLP-1 receptor agonists for type 2 diabetes showed no significant increase in major cardiovascular events (MACE), with an overall odds ratio of 0.74, suggesting these medications are not harmful to heart health.

In placebo-controlled studies, GLP-1 receptor agonists demonstrated a significant reduction in MACE risk (odds ratio of 0.46), indicating potential cardiovascular safety, while results from active comparator studies showed no significant difference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 receptor agonists and cardiovascular events: a meta-analysis of randomized clinical trials. Monami, M., Cremasco, F., Lamanna, C., et al.[2021]

Exenatide effectively improves glycemic control in patients with Type 2 diabetes by enhancing insulin secretion and suppressing appetite, leading to significant reductions in HbA1c and an average weight loss of 2 kg when used alongside metformin or sulfonylureas.

The treatment is generally well tolerated, with nausea being the most common side effect that decreases over time, and it poses a low risk of hypoglycemia, particularly when not combined with sulfonylureas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide: incretin therapy for patients with Type 2 diabetes mellitus. Tahrani, AA., Piya, MK., Barnett, AH.[2019]

Incretin-based therapies, like exenatide, effectively manage Type 2 diabetes by enhancing insulin secretion in response to glucose, addressing key metabolic issues without a high risk of hypoglycemia.

Exenatide not only helps control blood sugar levels but also promotes weight loss and reduces caloric intake, making it a beneficial option for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide, a GLP-1 agonist in the treatment of Type 2 diabetes. Sennik, D., Ahmed, F., Russell-Jones, D.[2019]

Metformin is the first-line treatment for type 2 diabetes but often has limited efficacy over time, leading to the need for additional medications due to its gastrointestinal side effects and contraindications in certain patients.

Incretin-based therapies, particularly GLP-1 receptor agonists, are emerging as effective add-on treatments that can help achieve glycemic control while potentially offering cardiovascular benefits and improving β-cell function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological management of type 2 diabetes: the potential of incretin-based therapies. Charbonnel, B., Cariou, B.[2022]

Intensive glucose control in type 2 diabetes can delay the onset and progression of both microvascular and possibly macrovascular diseases, highlighting the importance of early intervention and management strategies.

Combination therapy using insulin with oral medications like metformin can effectively normalize blood sugar levels while minimizing the need for intensive insulin regimens, although insulin therapy is associated with weight gain and hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin therapy in type 2 diabetes. Mudaliar, S., Edelman, SV.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes: new and future developments in treatment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for the treatment of patients with type 2 diabetes mellitus: rationale and specific agents. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Evidence-based recommendations for insulin intensification strategies after basal insulin in type 2 diabetes. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical application of incretin-based therapy: therapeutic potential, patient selection and clinical use. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical application of incretin-based therapy: therapeutic potential, patient selection and clinical use. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

New therapeutic options: management strategies to optimize glycemic control. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of incretin based therapies: clinical trial data. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. [2021]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Alogliptin: a novel molecule for improving glycemic control in type II diabetes mellitus. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 receptor agonists and cardiovascular events: a meta-analysis of randomized clinical trials. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Exenatide: incretin therapy for patients with Type 2 diabetes mellitus. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Exenatide, a GLP-1 agonist in the treatment of Type 2 diabetes. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Pharmacological management of type 2 diabetes: the potential of incretin-based therapies. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Insulin therapy in type 2 diabetes. [2019]