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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
Must not have
Renal insufficiency
BMI >45
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks (at baseline and at 16 weeks)

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.
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.
What are the potential side effects?
Mirabegron may cause high blood pressure, urinary tract infections, headache, dizziness, nausea and could potentially increase heart rate.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidneys do not work well.
Select...
My BMI is over 45.
Select...
I regularly take medication for diabetes.
Select...
I cannot take Mirabegron due to health reasons.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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%
headache
7%
asthma
7%
diarrhea
7%
gastritis
7%
urinary tract infection
7%
fatigue
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
2,443 Previous Clinical Trials
4,331,079 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
~1 spots leftby Dec 2024
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