Clinical trial

Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)

Name

P160916J

Description

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 arms

Trial start

2023-05-20

Estimated PCD

2026-02-01

Trial end

2026-05-01

Status

Recruiting

Phase

Early phase I

Treatment

Glibenclamide

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

Arms:

Glibenclamide oral

Pharmacokinetics study

0.2 ml blood sampling at 3 hours, 6 hours, 10 hours and 24 hours after the first administration and after 24 hours of blood glucose stabilization. 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

Arms:

Glibenclamide oral

C-peptide proinsulin ratio

blood sampling at before first administration and after 24 hours for measurement of C-peptide proinsulin ratio

Arms:

Glibenclamide oral

Blood glucose on fluorinated tube

0.3 ml blood sampling at 3 hours, 6 hours, 10 hours and 24 hours after the first administration and after 24 hours of blood glucose stabilization.

Arms:

Glibenclamide oral

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 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.

Arms:

Glibenclamide oral

glycose holter monitor

glucose levels will be collected with a smarter continuous glucose monitoring system, placed on inclusion and until the end of treatment

Arms:

Glibenclamide oral

Size

Primary endpoint

Blood glucose control

At 72 hours after the first administration

Eligibility criteria

Inclusion Criteria: * 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) * Enteral feeding considered before inclusion or already established * Consent obtained from persons holding parental authority * Beneficiary of social security Exclusion Criteria * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

Updated at

2023-06-18

1 organization

6 products

4 indications

Organization

Assistance Publique - Hôpitaux de Paris

Product

Glibenclamide

Indication

Hypoglycemia

Indication