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Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Apr 15, 2026 to Feb 14, 2022 · Site details revisedv15 Show 2 more changesShow less
    • Start date changed from estimate of Apr 15, 2026 to Feb 14, 2022
    • Site details revised
  2. Study title shortened, about 6 wordsv14 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Terminated to Not Yet Recruiting Primary completion date: Jul 9, 2025 to Dec 30, 2027 · Start date: Feb 14, 2022 to Apr 15, 2026 · Enrollment target: 26 to 30 · 7 morev13 Show 10 more changesShow less
    • Primary completion date: Jul 9, 2025 to Dec 30, 2027
    • Start date: Feb 14, 2022 to Apr 15, 2026
    • Enrollment target: 26 to 30
    • Completion date: Jul 9, 2025 to Jul 15, 2028
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description shortened, about 80 words
    • Site contact updated
    • Study title expanded, about 8 words
    • Study arms: 2 to 1
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Terminated Sponsor's reason: Slow enrollment Enrollment target: estimated 36 to confirmed 26 · Primary completion date changed from estimate of Nov 30, 2025 to Jul 9, 2025 · Study completion date changed from estimate of Apr 30, 2026 to Jul 9, 2025 · 1 morev12 Show 4 more changesShow less
    • Enrollment target: estimated 36 to confirmed 26
    • Primary completion date changed from estimate of Nov 30, 2025 to Jul 9, 2025
    • Study completion date changed from estimate of Apr 30, 2026 to Jul 9, 2025
    • Site details revised
  5. Primary completion date: May 1, 2025 to Nov 30, 2025 Completion date: Oct 1, 2025 to Apr 30, 2026 · Site contact updatedv11 Show 2 more changesShow less
    • Completion date: Oct 1, 2025 to Apr 30, 2026
    • Site contact updated
Show 9 earlier versionsHide 9 earlier versions
  1. Secondary endpoints: 10 to 9v10 See this version in full on ClinicalTrials.gov ↗
  2. 2 versions Re-verified since Mar 1, 2022, no change to tracked fieldsv8-v9
  3. Eligibility criteria expanded, about 1 wordv7 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 15, 2021 to Feb 14, 2022 · Site details revisedv6 Show 2 more changesShow less
    • Start date changed from estimate of Nov 15, 2021 to Feb 14, 2022
    • Site details revised
  5. Start date: Sep 1, 2021 to Nov 15, 2021 Eligibility criteria expanded, about 28 words · Study description expanded, about 66 wordsv5 Show 2 more changesShow less
    • Eligibility criteria expanded, about 28 words
    • Study description expanded, about 66 words

    See this version in full on ClinicalTrials.gov ↗

  6. Start date: May 1, 2021 to Sep 1, 2021 Enrollment target: 30 to 36 · Study description expanded, about 4 wordsv4 Show 2 more changesShow less
    • Enrollment target: 30 to 36
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  7. Enrollment target: 20 to 30 Primary completion date: Sep 2021 to May 1, 2025 · Start date: Aug 22, 2020 to May 1, 2021 · Primary endpoint revised · 7 morev3 Show 10 more changesShow less
    • Primary completion date: Sep 2021 to May 1, 2025
    • Start date: Aug 22, 2020 to May 1, 2021
    • Primary endpoint revised
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Completion date: Sep 2021 to Oct 1, 2025
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 7 to 10
    • Study description expanded, about 39 words
    • Study arms: 1 to 2
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study title shortened, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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.
The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD)
Trial Details
NCT Number NCT04530383
Lead Sponsor University of Kansas Medical Center
Conditions Cystic Fibrosis-related Diabetes, Cystic Fibrosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov