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Active, Not Recruiting

NCT Number: NCT05687500

Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Transient; Hypoglycemia, Neonatal Female Urogenital Diseases and Pregnancy Complications Glibenclamide Adverse Reaction Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Urogenital Diseases

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Necker - Enfants malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glibenclamide

Drug

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

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.

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

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.

Primary outcomes

  1. Blood glucose control

    Time frame: At 72 hours after the first administration

    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)

Secondary outcomes

  1. Overall success of the treatment

    Time frame: At 36 week of amenorrhea corrected age

    Overall success of the treatment defined by continuation to the end of treatment without recourse to insulin.

  2. Blood glucose profile on glibenclamide

    Time frame: At the end of treatment assessed up to 15 days

    Time between the start of glibenclamide treatment and the 1st blood glucose < 10 mmol/l

  3. Blood glucose profile on glibenclamide

    Time frame: At the end of treatment assessed up to 15 days

    Time between the start of glibenclamide treatment and the 1st blood glucose < 8 mmol/l

  4. Blood glucose profile on glibenclamide

    Time frame: At the end of treatment assessed up to 15 days

    Proportion of time spent within the target blood glucose range (≥ 4 and < 10 mmol/l) during the period of glibenclamide treatment

  5. Blood glucose profile on glibenclamide

    Time frame: At the end of treatment assessed up to 15 days

    Proportion of time spent above the target level (≥ 10 mmol/l) during the period of glibenclamide treatment

  6. Blood glucose profile on glibenclamide

    Time frame: At the end of treatment assessed up to 15 days

    Proportion of time spent in hypoglycemia (< 2.6 mmol/l) during the period of glibenclamide treatment

  7. Duration of glibenclamide treatment

    Time frame: At the end of treatment assessed up to 15 days

    Duration of glibenclamide treatment.

  8. Nutritional intakes and growth

    Time frame: At the end of treatment assessed up to 15 days

    Carbohydrate

  9. Nutritional intakes and growth:

    Time frame: At the end of treatment assessed up to 15 days

    lipid

  10. Nutritional intakes and growth:

    Time frame: At the end of treatment assessed up to 15 days

    protein

  11. Nutritional intakes and growth:

    Time frame: At the end of treatment assessed up to 15 days

    mean caloric intake (kcal/kg/day) during treatment

  12. Nutritional intakes and growth:

    Time frame: At the end of treatment assessed up to 15 days

    mean weight gain (g/kg/day)

  13. Nutritional intakes and growth

    Time frame: At 36 week of amenorrhea corrected age

    Carbohydrate

  14. Nutritional intakes and growth:

    Time frame: At 36 week of amenorrhea corrected age

    lipid

  15. Nutritional intakes and growth:

    Time frame: At 36 week of amenorrhea corrected age

    protein

  16. Nutritional intakes and growth:

    Time frame: At 36 week of amenorrhea corrected age

    mean caloric intake (kcal/kg/day) during treatment

  17. Nutritional intakes and growth:

    Time frame: At 36 week of amenorrhea corrected age

    mean weight gain ((g/kg/day)

  18. Number of children with episode of hypoglycemia

    Time frame: At 72 hours after first administration

    Number of children with at least one episode of moderate (blood glucose < 2.6 mmol/l) or severe (< 1.5 mmol/l) hypoglycemia

  19. Number of children with episode of hypoglycemia

    Time frame: At the end of treatment assessed up to 15 days

    Number of children with at least one episode of moderate (blood glucose < 2.6 mmol/l) or severe (< 1.5 mmol/l) hypoglycemia

  20. Type of adverse reactions on glibenclamide

    Time frame: At 36 week of amenorrhea corrected age

    evaluation of the type of adverse reactions identified during the study

  21. Number of adverse reactions on glibenclamide

    Time frame: At 36 week of amenorrhea corrected age

    evaluation of number of adverse reactions identified during the study

  22. Number of participants with co-morbidity

    Time frame: At 36 week of amenorrhea corrected age

    Neonatal morbidity assessed at 36 WA corrected age: intraventricular haemorrhage, periventricular leukomalacia, retinopathy of premature newborns, haemodynamic disorders, ulcerative necrotising enterocolitis

  23. Mortality

    Time frame: At 36 week of amenorrhea corrected age

    Mortality will be assessed

  24. Dose adjustment

    Time frame: At the end of treatment assessed up to 15 days

    Number of dose adjustments, to evaluate the easy of use

  25. ease of use by caregivers

    Time frame: At day one of treatment

    Assessment scores by visual-analogue scale for ease of use by caregivers; 0 as the lowest score, 10 as the highest score

  26. ease of use by caregivers

    Time frame: At day two of treatment

    Assessment scores by visual-analogue scale for ease of use by caregivers; 0 as the lowest score, 10 as the highest score

  27. ease of use by caregivers

    Time frame: At day three of treatment

    Assessment scores by visual-analogue scale for ease of use by caregivers; 0 as the lowest score, 10 as the highest score

  28. Plasma concentrations of glibenclamide

    Time frame: At 3 hours after the first administration

    Evaluated by the pharmacokinetics study

  29. Plasma concentrations of glibenclamide

    Time frame: At 6 hours after the first administration

    Evaluated by the pharmacokinetics study

  30. Plasma concentrations of glibenclamide

    Time frame: At 10 hours after the first administration

    Evaluated by the pharmacokinetics study

  31. Plasma concentrations of glibenclamide

    Time frame: At 24 hours after the first administration

    Evaluated by the pharmacokinetics study

  32. Plasma concentrations of glibenclamide

    Time frame: At 24 hours of blood glucose stabilization

    Evaluated by the pharmacokinetics study

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: GALOP

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 18, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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