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The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

NCT05051436 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-02-03

No results posted yet for this study

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

DRUG

Mirabegron 50 MG

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

DRUG

Tadalafil 10 MG

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

DRUG

Placebo

Placebo will be administered for 14 weeks after baseline procedures.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Philip Kern

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05051436 on ClinicalTrials.gov