Mirabegron for Prediabetes

Phase-Based Progress Estimates
University of Kentucky, Lexington, KYPrediabetesMirabegron - Drug
35 - 65
All Sexes
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Prediabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 0 Secondary · Reporting Duration: 16 weeks (at baseline and at 16 weeks)

Week 16
Change in Body Composition
Change in Brown Adipose Tissue Activity
Change in Glucose Tolerance
Change in Insulin Secretion
Change in Peripheral Insulin Sensitivity
Change in Resting Metabolic Rate
Change in glycohemoglobin

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

13%loose stools
13%urinary incontinence
7%Sore throat
7%abdominal cramps
7%Heart palpitations
7%foot or knee pain
7%sinus infection
7%Erectile dysfunction
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02092181) in the Mirabegron ARM group. Side effects include: Constipation with 20%, Fatigue with 13%, loose stools with 13%, urinary incontinence with 13%, Sore throat with 7%.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

65 Total Participants · 2 Treatment Groups

Primary Treatment: Mirabegron · Has Placebo Group · Phase 2

Experimental Group · 1 Intervention: Mirabegron · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks (at baseline and at 16 weeks)

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
2,182 Previous Clinical Trials
4,088,832 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

Eligibility Criteria

Age 35 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) is between 27 and 45.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.