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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | December 13, 2021 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT05051436 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
- Principal investigator: Philip Kern, M.D. — University of Kentucky
- Study coordinator: Zach Leicht
- Email: zachary.leicht@uky.edu
- Phone: 859-218-1397
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.