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Mirabegron and Tadalafil for Prediabetes

This study is looking at how two medications, mirabegron and tadalafil, might affect blood sugar control in people with prediabetes and obesity. Researchers want to see if mirabegron alone, or in combination with tadalafil, can improve how your body handles sugar. You might be able to join if you are between 35 and 65 years old, have a specific A1C level (a measure of average blood sugar) between 5.7 and 6.4, and a body mass index (BMI) between 27 and 45. The study will compare these medications to a placebo (an inactive pill) over 14 weeks. The main goal is to see if these treatments improve your oral glucose tolerance test results.

Study design
This is an interventional study planning to enroll 96 participants. Participants will receive either mirabegron, tadalafil, or a placebo.
What's involved
You would take a study drug (mirabegron, tadalafil, or placebo) for 14 weeks. Your oral glucose tolerance will be measured at the beginning and end of this period.
Compensation
Not stated in the trial record.
Follow-up
Your glucose tolerance will be measured at 14 weeks, which appears to be the end of the study period.

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NCT05051436

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Recruiting
PHASE4Ages 35–65InterventionalTreatment
Philip Kern
~96 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:Mirabegron 50 MGTadalafil 10 MGPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oral glucose tolerance test
Measured over Baseline
+1 more outcome measured

Conditions

Pre-diabetes
Obesity

Explore related trials

ObesityPrediabetes

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Philip Kern, M.D. · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Zach Leicht
[email protected]
859-218-1397
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hemoglobin A1C between 5.7 and 6.4
Body mass index between 27 and 45

Exclusion

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

What this trial measures

  • Oral glucose tolerance testBaseline

    Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.

  • Oral glucose tolerance test14 weeks

    Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.