Pre-diabetesPhase 4NCT05051436
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
A Phase 4 study testing Mirabegron 50 MG and Tadalafil 10 MG in people with Pre-diabetes and Obesity, run by Philip Kern at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Obesity
- What is being tested?
- Mirabegron 50 MG and Tadalafil 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hemoglobin A1C between 5.7 and 6.4
- Body mass index between 27 and 45
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Zach Leicht, 859-218-1397, zachary.leicht@uky.edu
Philip Kern, M.D.
About this study
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.
- Conditions
- Pre-diabetes, Obesity
- Being tested
- Mirabegron 50 MG, Tadalafil 10 MG, Placebo
- Keywords
- Tadalafil, Mirabegron
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50 MGDrug
Mirabegron 50 mg/day will be administered for 14 weeks.
Tadalafil 10 MGDrug
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
PlaceboDrug
Placebo will be administered for 14 weeks after baseline procedures.
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron (M) | Experimental | Drug will be administered for 12 weeks after baseline procedures. Receives: Drug: Mirabegron 50 MG |
| Tadalafil (T) | Experimental | Drug will be administered for 12 weeks after baseline procedures. Receives: Drug: Tadalafil 10 MG |
| Mirabegron and Tadalafil (MT) | Experimental | Both drugs will be administered for 12 weeks after baseline procedures. Receives: Drug: Mirabegron 50 MG; Drug: Tadalafil 10 MG |
| Placebo (P) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral glucose tolerance test
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.
Measured: Baseline
Oral glucose tolerance test
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.
Measured: 14 weeks
Secondary outcomes (2)
Hemoglobin A1C
Participant hemoglobin A1C will be evaluated at baseline.
Measured: Baseline
Hemoglobin A1C
Participant hemoglobin A1C will be evaluated at 14 weeks.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start13 Dec 2021
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philip Kern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philip Kern, University of Kentucky
- Investigators
- Philip Kern, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051436
- Sponsor's protocol ID
- 55665
- Other IDs
- R01DK128033
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2021
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
- ClinicalTrials.gov ID
- NCT05051436
- Acronym / sponsor ID
- 55665
- Conditions
- Pre-diabetes, Obesity
- Keywords
- Tadalafil, Mirabegron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Philip KernUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mirabegron (M) | Experimental | Drug: Mirabegron 50 MGDrug will be administered for 12 weeks after baseline procedures. |
| Tadalafil (T) | Experimental | Drug: Tadalafil 10 MGDrug will be administered for 12 weeks after baseline procedures. |
| Mirabegron and Tadalafil (MT) | Experimental | Drug: Mirabegron 50 MG, Drug: Tadalafil 10 MGBoth drugs will be administered for 12 weeks after baseline procedures. |
| Placebo (P) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemoglobin A1C between 5.7 and 6.4
- Body mass index between 27 and 45
Key exclusion criteria (8 listed)
- Diabetes
- Chronic use of any antidiabetic medications
- Any unstable medical condition
- Use of steroids or daily use of NSAIDS
- History of chronic inflammatory conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirabegron 50 MGMirabegron 50 mg/day will be administered for 14 weeks. | Drug | Mirabegron (M), Mirabegron and Tadalafil (MT) |
| Tadalafil 10 MGTadalafil 10 mg/day will be administered for 14 weeks after baseline procedures. | Drug | Mirabegron and Tadalafil (MT), Tadalafil (T) |
| PlaceboPlacebo will be administered for 14 weeks after baseline procedures. | Drug | Placebo (P) |
Primary outcome
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.
2 secondary outcomes
Hemoglobin A1C
Time frame: Baseline
Hemoglobin A1C
Time frame: 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip Kern, M.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron 50 MG and Tadalafil 10 MG in people with Pre-diabetes and Obesity, run by Philip Kern at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zach Leicht (859-218-1397, zachary.leicht@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral glucose tolerance test (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.