NCT05687500

Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 34 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Transient hyperglycemia of premature newborns results from an overall decrease in insulin sensitivity, which is responsible at the beta cell level for abnormalities of intragranular cleavage of proinsulin into insulin, leading to reduced active insulin secretion. Intravenous administration of exogenous insulin can be used to combat insulin resistance and lower blood glucose, but it is difficult to manage in premature newborns and is associated with a substantial risk of hypoglycemia. Glibenclamide, which stimulates endogenous insulin secretion and can be administered orally, might be an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.

Conditions

• Transient; Hypoglycemia, Neonatal
• Preterm
• Glibenclamide Adverse Reaction

Interventions

Type	Name	Description
DRUG	Glibenclamide	Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk
BIOLOGICAL	Pharmacokinetics study	* 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.
BIOLOGICAL	C-peptide proinsulin ratio	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
BIOLOGICAL	Routine biological monitoring	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.

Timeline

• Start date: 2023-05-20
• Primary completion: 2026-11-20
• Completion: 2027-02-20
• First posted: 2023-01-18
• Last updated: 2025-11-20

Locations

1 site across 1 country: France