RECRUITING Phase 4 ClinicalTrials.gov

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Sponsor: Philip Kern • ClinicalTrials.gov ID: NCT05051436

Registry updated: 2026-08-31

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Description

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.

Interventions

Mirabegron 50 MG (Drug)
Mirabegron 50 mg/day will be administered for 14 weeks.
Tadalafil 10 MG (Drug)
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Placebo (Drug)
Placebo will be administered for 14 weeks after baseline procedures.

Eligibility 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

Conditions

Pre-diabetes Obesity

Locations

University of Kentucky — Lexington, Kentucky, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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