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Search / Trial NCT05051436

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Launched by PHILIP KERN · Sep 10, 2021

Trial Information

Current as of May 22, 2025

Recruiting

Keywords

Tadalafil Mirabegron

ClinConnect Summary

This clinical trial is studying how two medications, mirabegron and tadalafil, affect blood sugar levels in people who are at risk of developing diabetes, specifically those who are prediabetic and obese. The researchers believe that mirabegron can help improve how the body handles glucose, or sugar, and that combining it with tadalafil may enhance these benefits. Participants will be given one of these medications, a combination of both, or a placebo (a harmless pill with no active ingredients) for 14 weeks. The goal is to see if these treatments can help reverse prediabetes.

To be eligible for this trial, participants should be between 18 and 75 years old, have a specific range of blood sugar levels (Hemoglobin A1C between 5.7 and 6.4), and have a body mass index (BMI) between 27 and 45. However, individuals with diabetes, certain medical conditions, or those taking specific medications will not be able to participate. If you join the trial, you’ll be helping researchers understand how these medications work for people at risk of diabetes, and you may benefit from improved health outcomes.

Gender

ALL

Eligibility criteria

  • 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

About Philip Kern

Dr. Philip Kern is a distinguished clinical trial sponsor with extensive expertise in translational medicine and metabolic research. His work focuses on advancing innovative therapeutic approaches for obesity and related metabolic disorders, leveraging a strong foundation in clinical and preclinical studies. With a commitment to enhancing patient outcomes, Dr. Kern collaborates with multidisciplinary teams to design and implement rigorous clinical trials that adhere to the highest ethical and scientific standards. His contributions to the field are underscored by a track record of successful trial management and a dedication to fostering advancements in healthcare through research and development.

Locations

Lexington, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Philip Kern, M.D.

Principal Investigator

University of Kentucky

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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