NCT05051436 · Philip Kern
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
What this study is about
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 two or more treatments used together with tadalafil.
View original scientific description
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.
Interventions
DRUG
Mirabegron 50 MG
Mirabegron 50 mg/day will be administered for 14 weeks.
DRUG
Tadalafil 10 MG
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
DRUG
Placebo
Placebo will be administered for 14 weeks after baseline procedures.
Primary outcome measures
Oral glucose tolerance test
Time frame: Baseline
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.
Oral glucose tolerance test
Time frame: 14 weeks
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Hemoglobin A1C between 5.7 and 6.4
- Body mass index between 27 and 45
Exclusion criteria
- 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
Where
- Lexington, Kentucky
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2026 · Source of record for eligibility and locations