The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

August 26, 2026 updated by: Philip Kern
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Philip Kern, M.D.
  • Phone Number: 859-218-1394
  • Email: pake222@uky.edu

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
        • Principal Investigator:
          • Philip Kern, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirabegron (M)
Drug will be administered for 12 weeks after baseline procedures.
Drug: Mirabegron 50 MG
Mirabegron 50 mg/day will be administered for 14 weeks.
Experimental: Tadalafil (T)
Drug will be administered for 12 weeks after baseline procedures.
Drug: Tadalafil 10 MG
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Experimental: Mirabegron and Tadalafil (MT)
Both drugs will be administered for 12 weeks after baseline procedures.
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.
Placebo Comparator: Placebo (P)
Drug: Placebo
Placebo will be administered for 14 weeks after baseline procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral glucose tolerance test
Time Frame: Baseline
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.
Baseline
Oral glucose tolerance test
Time Frame: 14 weeks
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: Baseline
Participant hemoglobin A1C will be evaluated at baseline.
Baseline
Hemoglobin A1C
Time Frame: 14 weeks
Participant hemoglobin A1C will be evaluated at 14 weeks.
14 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat biopsy
Time Frame: Baseline
Beiging of fat as measured in the lab by histochemistry.
Baseline
Fat biopsy
Time Frame: 14 weeks
Beiging of fat as measured in the lab by histochemistry.
14 weeks
Muscle biopsy
Time Frame: Baseline
Fiber type, as measured in the lab by histochemistry.
Baseline
Muscle biopsy
Time Frame: 14 weeks
Fiber type, as measured in the lab by histochemistry.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philip Kern

Collaborators

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

Investigators

  • Principal Investigator: Philip Kern, M.D., University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55665
  • R01DK128033 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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