GALOP : Oral glibenclamide in hyperglycaemia of the premature infant

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

20 May 2023 → 8 Jan 2026

Decision date (initial)

2024-06-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ministry of Health - PHRC

External identifiers

EU CT number

2024-512230-15-00

EudraCT number

2021-005766-18

ClinicalTrials.gov

NCT05687500

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy, Therapy

To assess the 72-hour efficacy of an enteral suspension of glibenclamide in controlling transient hyperglycaemia in premature infants weighing less than 1500 g.

Secondary objectives 6

1. • To assess the overall efficacy of a suspension of glibenclamide in controlling hyperglycaemia
2. • To assess the glycaemic profile under glibenclamide (time to glycaemic control, time spent in glycaemic target range);
3. • To assess caloric intake and early neonatal growth in premature infants treated with glibenclamide;
4. • To assess the safety and tolerability of glibenclamide;
5. • To assess the ease of use of glibenclamide;
6. • To evaluate the pharmacokinetics of enteral glibenclamide;

Conditions and MedDRA coding

Transient hyperglycaemia in premature infants

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. - Newborn less than 34 weeks post-mentrual age
2. - Birth weight < 1500 g
3. - Gestational age < 32 weeks
4. - Hyperglycaemia ≥ 10 mmol/l on 2 measurements taken at least 3 hours apart after eventual reduction of glucose intakes following each unit’s protocol (if not consecutive, within a maximum interval of 9 hours)
5. - Secure venous access point (umbilical venous catheter or epicutaneo-cava catheter)
6. - Enteral feeding considered or already started prior to enrolment
7. - Consent obtained from legal guardians
8. - Beneficiary of social security

Exclusion criteria 11

1. - Contraindication to enteral feeding (at the discretion of the clinician responsible for the child)
2. - Hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipients
3. - Patient with continuous insulin IV administration
4. - Patient treated with miconazole
5. - Severe birth defect, including cardiac malformation associated with a risk of myocardial ischemia
6. - Severe sepsis requiring mechanical ventilation or haemodynamic support
7. - Severe renal dysfunction (serum creatinine > 120 µmol/l)
8. - Severe hepatocellular failure (if assessment indicated: V factor less than the standard laboratory range for the age) and/or severe cholestasis (conjugated bilirubin > 50 µmol/L)
9. - Hyperglycaemia associated with an error in administering glucose infusion
10. - Profound hypophosphoremia (< 1 mmol/l)
11. - RCIU PN < 3ème perc. (définition Audipog)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 11

1. • Overall success of the treatment defined by continuation to the end of treatment without insulin use.
2. • Glycaemic profile under glibenclamide (see protocol)
3. • Duration of glibenclamide treatment.
4. • Nutritional intakes and growth (see protocol)
5. • Number of children with at least one episode of moderate (blood glucose < 2.6 mmol/l) or severe (< 1.5 mmol/l) hypoglycaemia within the first 72 hours of treatment and for the duration of treatment
6. • Number and type of adverse reactions to glibenclamide (see protocol)
7. • Neonatal morbidity assessed at 36 weeks post-menstrual age: intraventricular haemorrhage, periventricular leukomalacia, retinopathy of premature newborns, haemodynamic disorders, necrotising enterocolitis
8. • Mortality at 36 weeks post-menstrual age
9. • Number of dose adjustments
10. • Ease of use assessment score by caregivers
11. • Plasma concentrations of glibenclamide

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

KERMORVANT Elsa (Coordinating investigator)

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

EL AAMRI Touria

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications