The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Philip Kern · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05051436
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 35–65 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 96
- US sites recruiting
- 1
- Study start
- December 13, 2021
- Record last updated
- August 31, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Mirabegron 50 MG; Tadalafil 10 MG; Placebo
Conditions: Pre-diabetes; Obesity
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
University of Kentucky
Lexington, KY 40536
Site contact: Zach Leicht · 859-218-1397 · zachary.leicht@uky.edu
Study contacts (from the official record)
- Zach Leicht · 859-218-1397 · zachary.leicht@uky.edu
- Philip Kern, M.D. · 859-218-1394 · pake222@uky.edu
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