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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 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%
0%
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

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.

Find a Location

Who is running the clinical trial?

Philip KernLead Sponsor
7 Previous Clinical Trials
354 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,439 Previous Clinical Trials
4,324,728 Total Patients Enrolled
Philip Kern, M.D.Principal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
109 Total Patients Enrolled

Media Library

Mirabegron (Beta-3 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05051436 — Phase 4
Prediabetes Research Study Groups: Placebo (P), Mirabegron and Tadalafil (MT), Mirabegron (M), Tadalafil (T)
Prediabetes Clinical Trial 2023: Mirabegron Highlights & Side Effects. Trial Name: NCT05051436 — Phase 4
Mirabegron (Beta-3 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05051436 — Phase 4
~5 spots leftby Dec 2024