The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05051436

Enrollment

Registered

2021-09-21

Start date

2021-12-13

Completion date

2026-08-01

Last updated

2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes, Obesity

Keywords

Tadalafil, Mirabegron

Brief 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.

Interventions

DRUGMirabegron 50 MG

Mirabegron 50 mg/day will be administered for 14 weeks.

DRUGTadalafil 10 MG

Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.

DRUGPlacebo

Placebo will be administered for 14 weeks after baseline procedures.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Oral glucose tolerance test	Baseline	Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.

Secondary

Measure	Time frame	Description
Hemoglobin A1C	Baseline	Participant hemoglobin A1C will be evaluated at baseline.

Countries

United States

Contacts

CONTACTZach Leicht

zachary.leicht@uky.edu859-218-1397

CONTACTPhilip Kern, M.D.

pake222@uky.edu859-218-1394

PRINCIPAL_INVESTIGATORPhilip Kern, M.D.

University of Kentucky

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026