The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Last updated: February 2, 2026
Sponsor: Philip Kern
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Obesity

Treatment

Tadalafil 10 MG

Placebo

Mirabegron 50 MG

Clinical Study ID

NCT05051436
55665
R01DK128033
  • Ages 35-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hemoglobin A1C between 5.7 and 6.4

  • Body mass index between 27 and 45

Exclusion

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

Study Design

Total Participants: 96
Treatment Group(s): 3
Primary Treatment: Tadalafil 10 MG
Phase: 4
Study Start date:
December 13, 2021
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Active - Recruiting

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