Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 35 to 65

Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Official title: The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Run by University of Kentucky · NCT05051436 · Data updated 2026-11-12

This study is testing if the medications mirabegron and tadalafil can help people with prediabetes improve their blood sugar levels over 14 weeks.

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Quick facts

PhasePhase 4
Study typeInterventional
Ages35 Years to 65 Years
SexAll
Enrollment96 (estimated)
SponsorUniversity of Kentucky
Academic / other
Locations1 site (Lexington, Kentucky)
StatusRecruiting
StartedDecember 13, 2021
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedAugust 31, 2026
Trial IDNCT05051436 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are obese individuals with a hemoglobin A1C between 5.7 and 6.4 who are prediabetic.

Probably not a fit

Patients with diabetes or those on chronic antidiabetic medications will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of mirabegron, a ß3 agonist, on glucose metabolism in obese, insulin-resistant individuals with prediabetes. Participants will receive either mirabegron, tadalafil, a combination of both, or a placebo over a 14-week period. The goal is to determine if these treatments can improve glucose homeostasis and potentially reverse prediabetes. The study will comprehensively analyze changes in glucose tolerance among the different treatment groups.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic approach to reversing prediabetes and improving metabolic health in obese individuals.

How similar studies have gone: While the combination of mirabegron and tadalafil is a novel approach, previous studies have shown promise in using mirabegron for metabolic improvements.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Hemoglobin A1C between 5.7 and 6.4
* Body mass index between 27 and 45

Exclusion Criteria:

* Diabetes
* Chronic use of any antidiabetic medications
* Any unstable medical condition
* Use of steroids or daily use of NSAIDS
* History of chronic inflammatory conditions
* Use of anticoagulants
* Contraindications to the use of mirabegron or tadalafil
* Any condition deemed risky by the study physician

Where it's running

  • University of Kentucky
    Lexington, Kentucky, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.