The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age35-65
SponsorPhilip Kern

About this trial

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.

Eligibility criteria

Qualifiers

Hemoglobin A1C between 5.7 and 6.4

Body mass index between 27 and 45

Disqualifiers

Diabetes

Chronic use of any antidiabetic medications

Any unstable medical condition

Use of steroids or daily use of NSAIDS

Trial design

Treatments tested in this trial

  • Mirabegron 50 MG
  • Tadalafil 10 MG
  • Placebo

Treatment groups

96 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Philip Kern

Lead sponsor

University of Kentucky

Sponsor institution

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

Collaborator