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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
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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