Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05051436

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Status
Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
96 (estimated)
Sponsor
Philip Kern · Academic / Other
Sex
All
Age
35 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGMirabegron 50 MGMirabegron 50 mg/day will be administered for 14 weeks.
DRUGTadalafil 10 MGTadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
DRUGPlaceboPlacebo will be administered for 14 weeks after baseline procedures.

Timeline

Start date
2021-12-13
Primary completion
2026-08-01
Completion
2026-08-01
First posted
2021-09-21
Last updated
2026-02-03

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05051436. Inclusion in this directory is not an endorsement.