The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

NCT ID: NCT05051436

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pre-diabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mirabegron (M)

Drug will be administered for 12 weeks after baseline procedures.

Group Type EXPERIMENTAL

Mirabegron 50 MG

Intervention Type DRUG

Mirabegron 50 mg/day will be administered for 14 weeks.

Tadalafil (T)

Drug will be administered for 12 weeks after baseline procedures.

Group Type EXPERIMENTAL

Tadalafil 10 MG

Intervention Type DRUG

Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.

Mirabegron and Tadalafil (MT)

Both drugs will be administered for 12 weeks after baseline procedures.

Group Type EXPERIMENTAL

Mirabegron 50 MG

Intervention Type DRUG

Mirabegron 50 mg/day will be administered for 14 weeks.

Tadalafil 10 MG

Intervention Type DRUG

Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.

Placebo (P)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered for 14 weeks after baseline procedures.

Interventions

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Mirabegron 50 MG

Mirabegron 50 mg/day will be administered for 14 weeks.

Intervention Type DRUG

Tadalafil 10 MG

Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.

Intervention Type DRUG

Placebo

Placebo will be administered for 14 weeks after baseline procedures.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Philip Kern

OTHER

Sponsor Role lead

Responsible Party

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Philip Kern

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Philip Kern, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Douglas Long, M.S.

Role: CONTACT

859-323-5438

Philip Kern, M.D.

Role: CONTACT

859-218-1394

Facility Contacts

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Douglas Long

Role: primary

859-323-5438

Other Identifiers

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R01DK128033

Identifier Type: NIH

Identifier Source: secondary_id

View Link

55665

Identifier Type: -

Identifier Source: org_study_id

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