Actively Recruiting

Phase 4
Age: 35Years - 65Years
All Genders
Healthy Volunteers
NCT05051436

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Led by Philip Kern · Updated on 2026-02-03

96

Participants Needed

1

Research Sites

241 weeks

Total Duration

On this page

Sponsors

P

Philip Kern

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.

CONDITIONS

Official Title

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Who Can Participate

Age: 35Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Hemoglobin A1C between 5.7 and 6.4
  • Body mass index between 27 and 45
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

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Research Team

Z

Zach Leicht

CONTACT

P

Philip Kern, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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