Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Up to 34 weeks
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Transient; Hypoglycemia, Neonatal, Preterm, Glibenclamide Adverse Reaction

Being tested

Glibenclamide, Pharmacokinetics study, C-peptide proinsulin ratio, Routine biological monitoring

Keywords

transient hypoglycemia, preterm, glibenclamide

Medical subject headings

Hypoglycemia, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• GlibenclamideDrug

  Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk

• Pharmacokinetics studyBiological

  • For the first 10 patients during the test phase, four 0.2 ml samples will be taken at H3, H6, H10, and H24 (+/- 1 hour) after the first dose; an additional sample will be taken for patients whose blood sugar levels stabilize beyond 24 hours, after 6 hours of stable blood sugar levels (4-10 mmol/l);
  • For subsequent patients included during phase II:
  • 1 sample of 0.2 ml within the first 24 hours of treatment, during a care assessment.
  • 1 sample of 0.2 ml within the first 24 hours of treatment, during a care assessment
  • 1 sample of 0.2 ml per day at each daily check-up as part of care during the treatment period.
  • In centers that are unable to perform the samples and the appropriate techniques for centralizing these PK points, these samples will not be taken.

  PK parameters of glibenclamide will be determined using nonlinear analysis: area under the plasma concentration time curve (AUC), absorption constant, apparent clearance and volume of distribution.

• C-peptide proinsulin ratioBiological

  blood sampling at before first administration and after 24 hours for measurement of C-peptide proinsulin ratio if it is impossible to collect both volumes, the C-peptide collection will be prioritized

• Routine biological monitoringBiological

  If there are not performed as part of standard care, biological monitoring of ALT, AST, complete blood count, hemostasis, urea, creatinine, blood ionogram, total bilirubin and conjugated bilirubin will be done before first administration at the following time frame : 48 hours after the first administration than each days during treatment period, and 48 hours after the end of treatment.

  Transaminases and hemostasis will be done only in case of clinical indication before the first administration.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Blood glucose control

   The primary evaluation criteria is 72 hours blood glucose control on glibenclamide treatment (success of the treatment). This is defined as the non-use of insulin and absence of severe hypoglycemia (< 1.5 mmol/l) or persistent moderate hypoglycemia (< 2.6 mmol/l in 2 successive measurements (dextro) at an interval of more than 3 hours)

   Measured: At 72 hours after the first administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Jan 2023
2. Study start20 May 2023
3. Primary completion30 Oct 2025
4. Study completion8 Jan 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Transient; Hypoglycemia, NeonatalStudies of the same condition, open and under way.
• More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.