Mirabegron for Prediabetes
Trial Summary
What is the purpose of this trial?
Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on chronic anti-diabetic medication, you would not be eligible to participate.
Is Mirabegron safe for human use?
How is the drug Mirabegron unique for prediabetes?
Mirabegron is unique for prediabetes because it is primarily used to treat overactive bladder by relaxing bladder muscles, and its use for prediabetes is novel, as there are no standard treatments specifically for prediabetes. This makes its mechanism of action different from typical diabetes medications, which usually focus on insulin regulation.678910
Research Team
Philip Kern, MD
Principal Investigator
University of Kentucky
Eligibility Criteria
This trial is for adults with prediabetes, characterized by slightly elevated blood sugar levels. Participants should have a BMI between 27-45 and not be on any chronic anti-diabetic medications. Those with kidney issues, cancer, unstable health conditions, inflammation or specific contraindications to Mirabegron cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Mirabegron or placebo for 16 weeks to assess effects on glucose metabolism and adipose tissue
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Mirabegron
- Placebo
Mirabegron is already approved in United States, European Union for the following indications:
- Overactive bladder (OAB)
- Neurogenic detrusor overactivity (NDO)
- Overactive bladder (OAB)
- Neurogenic detrusor overactivity (NDO)
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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