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The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 2026 → Jan 2027
See other at-risk trials from Philip Kern

Record History

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  1. Primary and study completion pushed from Aug 2026 to Jan 2027v8
  2. Primary and study completion dates: Jan 31, 2026 to Aug 2026
    • Site contact updated
    v7
  3. Primary completion date: Dec 31, 2024 to Jan 31, 2026
    • Study completion date: Feb 28, 2025 to Jan 31, 2026
    • Site contact updated
    v6
  4. Site contact updatedv5
  5. Re-verified, no change to tracked fieldsv4
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  1. Primary completion date: Dec 2023 to Dec 31, 2024
    • Study completion date: Dec 2023 to Feb 28, 2025
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2021 to Dec 13, 2021
    • Site details revised
    • Collaborators expanded, about 10 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Philip Kern
3 trials monitored
See 2 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
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 Details
NCT Number NCT05051436
Lead Sponsor Philip Kern
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Pre-diabetes, Obesity
Related terms Glucose Intolerance, Obesity
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov