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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights

Study Summary

This trial will study if the drugs mirabegron and tadalafil can improve glucose metabolism in obese, insulin-resistant people with prediabetes.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oral glucose tolerance test
Secondary outcome measures
Hemoglobin A1C
Other outcome measures
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

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

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
2,359 Previous Clinical Trials
4,315,399 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What particular conditions is Mirabegron 50 MG traditionally prescribed to address?

"Mirabegron 50 MG is frequently prescribed to ameliorate the symptoms of benign prostatic hyperplasia (BPH). This medication can also be used for treating an array of other issues, such as erectile dysfunction, neurogenic detrusor overactivity and overactive bladder syndrome (OABs)."

Answered by AI

Are there any open slots for participation in this medical trial?

"Yes, the clinicaltrials.gov listing confirms that this research initiative is actively enrolling participants since its inception on December 13th 2021. The study objective requires 96 patients to be recruited from one single site and was last updated on October 11th 2022."

Answered by AI

What potential risks are associated with using Mirabegron 50 MG?

"The safety of Mirabegron 50 MG was rated a 3, as it is currently in its fourth phase of trials and has already been approved."

Answered by AI

How many subjects are engaged in this experiment?

"Affirmative. The clinicaltrials.gov website points to this medical trial as being open for recruitment, which first began on December 13th 2021 and the study was last updated on October 11th 2022. 96 patients need to be enrolled at a single site."

Answered by AI

Do any other studies exist that have evaluated the efficacy of Mirabegron 50 MG?

"Presently, 25 medical studies for Mirabegron 50 MG are underway with 5 of them in the final stage. Many of these trials are located near Shibīn Al Kawm, Menoufia; however, there are 246 sites conducting research on this medication worldwide."

Answered by AI

Is enrollment for this trial accessible to those who are not yet of retirement age?

"The target population for this investigation consists of people aged 35 to 65."

Answered by AI

Could I gain access to this experiment?

"This research is seeking 96 participants between the ages of 35 and 65 who are diagnosed with obesity. To be eligible, patients must possess a body mass index that falls within 27-45."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
18 - 65
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have a heart condition and my fat is all in my chest and surrounding my heart. Hard to exercise because my legs are thin and the upper body weight is too much and puts too much stress on my joints in legs. It’s a vicious cycle. I am also post menopausal and hard to lose weight. I also have stress with being a full time caregiver for my mom. I just can’t get my weight under control.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Philip Kern 2021. "The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05051436.
All > Prediabetes > Cialis
~21 spots leftby Dec 2024
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