Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)

Study acronym: GALOP
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Apr 30, 2026 to Jan 8, 2026
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 11 of 32 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Nov 20, 2026 to Oct 30, 2025
    • Study completion date: Feb 20, 2027 to Apr 30, 2026
    • Site details revised
    v6
  3. Collaborators expanded, about 5 wordsv5
  4. Enrollment target: 45 to 35
    • Interventions: Blood glucose on fluorinated tube (Biological), C-peptide proinsulin ratio (Biological), Glibenclamide (Drug), Pharmacokinetics study… to C-peptide proinsulin ratio (Biological), Glibenclamide (Drug), Pharmacokinetics study (Biological), Routine biological monitoring…
    • Site contact updated
    v4
  5. Primary completion date: Feb 2026 to Nov 20, 2026
    • Study completion date: May 2026 to Feb 20, 2027
    • Site contact updated
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Dec 2025 to Feb 2026
    • Study completion date: Mar 2026 to May 2026
    • Start date changed from estimate of Mar 2023 to May 20, 2023
    • Site details revised
    • Study title expanded, about 2 words
  7. Study First Submitted
  • 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 confirm hypothesis that Glibenclamide can be administered orally and is an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.
Trial Details
NCT Number NCT05687500
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions
(from sponsor)		 Transient; Hypoglycemia, Neonatal, Preterm, Glibenclamide Adverse Reaction
Related terms Hypoglycemia, Premature Birth
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov