Mirabegron + Tadalafil for Prediabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing whether mirabegron, a drug that helps the body use sugar better, can improve blood sugar levels in obese, insulin-resistant people who are prediabetic. Mirabegron is a β3-adrenergic receptor agonist initially approved for treating overactive bladder, with potential benefits for metabolic diseases. The study also looks at whether adding tadalafil, another drug, can make mirabegron work even better. Participants will be treated for several months.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using antidiabetic medications, steroids, daily NSAIDs, or anticoagulants.
Is the combination of Mirabegron and Tadalafil safe for humans?
How is the drug Mirabegron + Tadalafil unique for prediabetes?
Mirabegron + Tadalafil is unique for prediabetes as it combines two drugs typically used for other conditions: Mirabegron, which is used for overactive bladder, and Tadalafil, known for treating erectile dysfunction. This combination is novel for prediabetes, as there are no standard treatments specifically targeting this condition.678910
Who Is on the Research Team?
Philip Kern, M.D.
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
This trial is for adults with prediabetes, characterized by a Hemoglobin A1C level of 5.7 to 6.4 and a body mass index (BMI) between 27 and 45. It's not suitable for those with contraindications to mirabegron or tadalafil, users of steroids/NSAIDs/anticoagulants regularly, people with chronic inflammation, diabetes, on antidiabetic meds, or any unstable medical condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Procedures
Baseline procedures conducted before treatment initiation
Treatment
Participants receive mirabegron, tadalafil, both, or placebo for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mirabegron
- Placebo
- Tadalafil
Mirabegron is already approved in United States, European Union for the following indications:
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Who Is Running the Clinical Trial?
Philip Kern
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator