What side effects are associated with this type of intervention?

Common treatments for prediabetes include lifestyle changes, metformin, and medications like Mirabegron (a ß3 agonist) and Tadalafil. Mirabegron is generally well-tolerated but can cause side effects such as increased heart rate, headache, and urinary tract infections. Tadalafil, primarily used for erectile dysfunction, may cause headaches, indigestion, back pain, and muscle aches. Metformin, another common treatment, can lead to gastrointestinal issues like nausea and diarrhea. Lifestyle changes, including diet and exercise, are typically safe but require significant patient commitment.

What prior FDA approvals exist?

The provided context does not mention any specific FDA approvals for the treatment of prediabetes. However, it does discuss various treatments for type 2 diabetes, such as GLP-1 receptor agonists (e.g., liraglutide, exenatide) and SGLT2 inhibitors (e.g., dapagliflozin), which improve glucose metabolism and have been approved for use in children and adolescents with type 2 diabetes. These treatments, while not specifically approved for prediabetes, may offer insights into potential therapeutic approaches for improving glucose metabolism in prediabetic patients.

What other types of research exist?

Promising novel alternatives to Mirabegron for prediabetes patients include small molecule glucagon receptor antagonists (GCGR antagonists) and incretin-based therapies such as GLP-1 analogues and DPP-4 inhibitors. These treatments have shown potential in improving glucose metabolism and glycemic control.

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Beta-3 Agonist

Mirabegron + Tadalafil for Prediabetes

Phase 4

Recruiting

Led By Philip Kern, M.D.

Research Sponsored by Philip Kern

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Use of steroids or daily use of NSAIDS

Contraindications to the use of mirabegron or tadalafil

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether mirabegron, a drug that helps the body use sugar better, can improve blood sugar levels in obese, insulin-resistant people who are prediabetic. Mirabegron is a β3-adrenergic receptor agonist initially approved for treating overactive bladder, with potential benefits for metabolic diseases. The study also looks at whether adding tadalafil, another drug, can make mirabegron work even better. Participants will be treated for several months.

Who is the study for?

This trial is for adults with prediabetes, characterized by a Hemoglobin A1C level of 5.7 to 6.4 and a body mass index (BMI) between 27 and 45. It's not suitable for those with contraindications to mirabegron or tadalafil, users of steroids/NSAIDs/anticoagulants regularly, people with chronic inflammation, diabetes, on antidiabetic meds, or any unstable medical condition.

What is being tested?

The study tests if mirabegron (a drug that activates ß3 receptors) alone or combined with tadalafil (commonly used for erectile dysfunction), can improve blood sugar control in prediabetics over placebo after 14 weeks. The goal is to see if these treatments can reverse prediabetes in obese individuals resistant to insulin.

What are the potential side effects?

Possible side effects include increased heart rate and blood pressure from mirabegron and headaches, indigestion or muscle pain from tadalafil. Side effects may vary when the drugs are taken separately compared to together.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I use steroids or NSAIDs every day.

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I cannot take mirabegron or tadalafil due to health reasons.

Select...

I regularly take medication for diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 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

Oral glucose tolerance test

Secondary study objectives

Hemoglobin A1C

Other study objectives

Fat biopsy

Muscle biopsy

Side effects data

From 2023 Phase 4 trial • 54 Patients • NCT04907032

11%

transient leg swelling from PTNS

11%

Urinary Tract Infection

100%

80%

60%

40%

20%

Study treatment Arm

Posterior Tibial Nerve Stimulation Plus Placebo

Posterior Tibial Nerve Stimulation With Mirabegron

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Tadalafil (T)Experimental Treatment1 Intervention

Drug will be administered for 12 weeks after baseline procedures.

Group II: Mirabegron and Tadalafil (MT)Experimental Treatment2 Interventions

Both drugs will be administered for 12 weeks after baseline procedures.

Group III: Mirabegron (M)Experimental Treatment1 Intervention

Drug will be administered for 12 weeks after baseline procedures.

Group IV: Placebo (P)Placebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirabegron 50 MG

2022

Completed Phase 4

~100

Tadalafil 10 MG

2018

N/A

~250

0 / 3Eligibility criteria met

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

Prediabetes treatments often aim to improve glucose metabolism and insulin sensitivity. Mirabegron, a ß3 agonist, enhances glucose metabolism by stimulating brown adipose tissue, which increases energy expenditure and improves insulin sensitivity. This is particularly important for prediabetes patients as it can help reverse insulin resistance and prevent the progression to type 2 diabetes. Other common treatments include lifestyle modifications such as diet and exercise, which improve insulin sensitivity and glycemic control, and medications like metformin, which decreases hepatic glucose production and increases peripheral glucose uptake. These mechanisms are crucial for managing prediabetes and reducing the risk of developing type 2 diabetes.

Clinical potentials of ginseng polysaccharide for treating gestational diabetes mellitus.Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.Combination immunotherapies for type 1 diabetes mellitus.