RightFit
RecruitingPhase 4

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether mirabegron, tadalafil, or both help people with prediabetes control blood sugar. It is for people with prediabetes and a body mass index (BMI) between 27 and 45. Treatment lasts 14 weeks and is compared with a placebo, a treatment with no active drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A1C between 5.7 and 6.4. This blood test measures average blood sugar.
  • Body mass index (BMI) between 27 and 45. BMI is a measure based on height and weight.

Who can't join

  • Diabetes.
  • Long-term use of any diabetes medicine.
  • Any medical condition that is not stable.
  • Use of steroids or daily use of NSAIDs, pain medicines such as ibuprofen.
  • A history of long-term conditions that cause inflammation, such as swelling.
  • Use of blood thinners.
  • Any medical reason you cannot safely take mirabegron or tadalafil.
  • Any condition the study doctor thinks would make joining risky.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 anticoagulants * Contraindications to the use of mirabegron or tadalafil * Any condition deemed risky by the study physician

Study sites (1)

KY