Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
35 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
Philip Kern · Other
Who this trial is looking for
This trial is looking for people with prediabetes who are overweight or obese. Participants will take either mirabegron, tadalafil, both medications, or a placebo for 14 weeks to see how these treatments affect blood sugar levels.
Are You a Good Fit for This Trial?
You may be able to join if
I have a hemoglobin A1C between 5.7 and 6.4
My body mass index is between 27 and 45
You may not be able to join if
I have diabetes
I use any antidiabetic medications regularly
I have any unstable medical condition
I use steroids or take NSAIDs every day
I have a history of chronic inflammatory conditions
I use anticoagulants
I have contraindications to mirabegron or tadalafil
I have any condition that my study doctor considers risky
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 mirabeg…
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.
Trial Locations
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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…
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
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