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SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from University of Minnesota

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified
    • Results posted: Sep 21, 2026
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Notable Enrollment target: 12 to 8
    • Primary endpoints revised (2)
    • Secondary endpoints: details revised at 1 of 1 entry
    v9
  3. Notable Enrollment target: 8 to 12
    • Primary endpoints: 1 to 2
    • Secondary endpoints expanded, about 2 words
    v8
  4. Notable Start date: Oct 16, 2023 to Jan 8, 2024
    • Primary completion date: Dec 23, 2025 to Jun 3, 2025
    v7
  5. Minor Primary completion date changed from estimate of Dec 31, 2025 to Dec 23, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Start date: Dec 30, 2023 to Oct 16, 2023
    v6
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  1. Notable Lead sponsor: Amir Moheet to University of Minnesota
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 15 to confirmed 8
    • Site details revised
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Minor Study title shortened, about 12 wordsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period. Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial.
Trial Details
NCT Number NCT06149793
Lead Sponsor University of Minnesota
Conditions
(from sponsor)
Cystic Fibrosis-related Diabetes, Cystic Fibrosis
Related terms Cystic Fibrosis
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov