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Beta-3 Adrenergic Agonist

Mirabegron for Prediabetes

Phase 2
Recruiting
Led By Philip Kern, MD
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 16 weeks (at baseline and at 16 weeks)
Awards & highlights

Study Summary

This trial will assess the effects of the medication mirabegron on glucose tolerance and adipose tissue in prediabetic patients.

Who is the study for?
This trial is for adults with prediabetes, characterized by slightly elevated blood sugar levels. Participants should have a BMI between 27-45 and not be on any chronic anti-diabetic medications. Those with kidney issues, cancer, unstable health conditions, inflammation or specific contraindications to Mirabegron cannot join.Check my eligibility
What is being tested?
The study is testing the effects of Mirabegron (a medication used for overactive bladder) on improving blood sugar control and fat tissue function in people with prediabetes compared to a placebo.See study design
What are the potential side effects?
Mirabegron may cause high blood pressure, urinary tract infections, headache, dizziness, nausea and could potentially increase heart rate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks (at baseline and at 16 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks (at baseline and at 16 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
Change in Body Composition
Change in Brown Adipose Tissue Activity
Change in Glucose Tolerance
+4 more

Side effects data

From 2019 Phase 4 trial • 28 Patients • NCT02086188
7%
urinary tract infection
7%
asthma
7%
gastritis
7%
fatigue
7%
diarrhea
7%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Mirabegron

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MirabegronExperimental Treatment1 Intervention
Participants in this group will receive Mirabegron for 16 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants in the group will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron
2008
Completed Phase 4
~18640

Find a Location

Who is running the clinical trial?

Philip KernLead Sponsor
7 Previous Clinical Trials
385 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,121 Total Patients Enrolled
Philip Kern, MDPrincipal Investigator - University of Kentucky
University of Kentucky, University of Kentucky Albert B. Chandler Hospital
New York Medical College (Medical School)
Montefiore M C-H&L Moses Div (Residency)
4 Previous Clinical Trials
144 Total Patients Enrolled

Media Library

Mirabegron (Beta-3 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04666636 — Phase 2
Prediabetes Research Study Groups: Placebo, Mirabegron
Prediabetes Clinical Trial 2023: Mirabegron Highlights & Side Effects. Trial Name: NCT04666636 — Phase 2
Mirabegron (Beta-3 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04666636 — Phase 2
Prediabetes Patient Testimony for trial: Trial Name: NCT04666636 — Phase 2

Frequently Asked Questions

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

To what extent have other clinical trials explored the efficacy of Mirabegron?

"To date, there are 11 different clinical trials examining the efficacy of Mirabegron. Of these studies, 2 have already reached Phase 3 and most originate from Marseille and Seoul Teugbyeolsi with a total of 58 research centres conducting investigations into this drug's effects."

Answered by AI

Who meets the criteria to be included in this medical experiment?

"The current recruitment effort is seeking 65 individuals with prediabetes, aged 35-65. Those interested in participating should apply soon as only a limited number of spots are available."

Answered by AI

Are there any available openings in this medical experiment for participants?

"According to the data on clinicaltrials.gov, this experiment is still recruiting volunteers. The trial was first posted in December of 2020 and last updated a year later in 2021."

Answered by AI

Is enrollment open to individuals who are over 40 years of age for this research project?

"According to the conditions for inclusion, participants must be between 35 and 65 years of age. There are 12 trials catered towards minors under 18 years old and 166 studies aimed at seniors above 65."

Answered by AI

How many participants are enlisted in the current clinical trial?

"Affirmative. The information hosted on the clinicaltrials.gov website points to this medical trial continuing its recruitment efforts, having been first posted on December 7th 2020 and last updated on December 13th 2021. 65 patients are required from a single centre for participation in the study."

Answered by AI

Has the U.S. Food & Drug Administration sanctioned Mirabegron?

"Mirabegron is classified as a Phase 2 medication, indicating that there are some clinical studies attesting to its safety but none affirming efficacy. Hence, it was assigned a score of two on our ranking system."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I m prediabetic and want to help others as well as myself.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Mechanisms for Activation of Beige Adipose Tissue in Humans
Philip Kern 2020. "Mechanisms for Activation of Beige Adipose Tissue in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04666636.
All > Prediabetes > Diabetes
~11 spots leftby Dec 2024
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