Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)

NCT05687500 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: P160916J2021-005766-18
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transient; Hypoglycemia, Neonatal; Preterm; Glibenclamide Adverse Reaction

Keywords

transient hypoglycemia; preterm; glibenclamide

Outcome Measures

Primary Outcomes (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)

  At 72 hours after the first administration

Secondary Outcomes (32)

• Overall success of the treatment

  At 36 week of amenorrhea corrected age

• Blood glucose profile on glibenclamide

  At the end of treatment assessed up to 15 days

• Blood glucose profile on glibenclamide

  At the end of treatment assessed up to 15 days

• Blood glucose profile on glibenclamide

  At the end of treatment assessed up to 15 days

• Blood glucose profile on glibenclamide

  At the end of treatment assessed up to 15 days

Study Arms (1)

Glibenclamide oral

EXPERIMENTAL

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

Drug: Glibenclamide; Biological: Pharmacokinetics study; Biological: C-peptide proinsulin ratio; Biological: Routine biological monitoring

Interventions

Glibenclamide DRUG

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

Glibenclamide oral

Pharmacokinetics study BIOLOGICAL

* 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.

Glibenclamide oral

C-peptide proinsulin ratio BIOLOGICAL

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

Glibenclamide oral

Routine biological monitoring BIOLOGICAL

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.

Glibenclamide oral

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn less than 34 week of amenorrhea corrected age
• Birth weight \< 1500 g
• Birth term \< 32 week of amenorrhea
• Hyperglycemia ≥ 10 mmol/l in 2 measurements, 3 hours apart after potential reduction of glucose intakes following each department's protocol
• Secure venous access point (umbilical venous catheter or epicutaneo-cava catheter)
• Consent obtained from persons holding parental authority
• Beneficiary of social security

You may not qualify if:

• Contraindication to enteral feeding (at the discretion of the clinician responsible for the child)
• Contraindication to glibenclamide according to current SPC
• Foetal growth restriction (FGR) birth weight \< 3rd percentile (AUDIPOG definition)
• Severe birth defect, including cardiac malformation associated with a risk of myocardial ischemia
• Severe sepsis requiring mechanical ventilation or haemodynamic support
• Severe renal dysfunction (serum creatinine \> 120 µmol/l)
• Severe hepatocellular failure (V factor less than the standard laboratory range for the age) and/or severe cholestasis (\> 50 µmol/L)
• Hyperglycemia associated with an error in administering glucose infusion
• Profound hypophosphoremia (\< 1 mmol/l)
• Hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipients
• Patient with continuous insulin IV administration
• Patient treated with miconazole

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hopital Necker - Enfants malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Hypoglycemia; Premature Birth

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Jacques BELTRAND, Pr

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Michel POLAK

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Delphine MITANCHEZ

  CHRU de Tours

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 18, 2023
• Study Start: May 20, 2023
• Primary Completion: October 30, 2025
• Study Completion: April 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)