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Study on Oral Glibenclamide for Managing High Blood Sugar in Premature Infants Weighing Less Than 1500g

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as transient hyperglycemia in premature infants. Transient hyperglycemia is a temporary increase in blood sugar levels that can occur in babies born before their due date. The study will use a treatment called glibenclamide, which is given as an oral suspension. This means the medicine is in liquid form and can be taken by mouth or through a feeding tube.

The purpose of the study is to see how well glibenclamide works in controlling high blood sugar levels in premature infants who weigh less than 1500 grams. The study will last for a short period, specifically looking at the effects over 72 hours. During this time, researchers will monitor the infants to see if the treatment helps manage their blood sugar without needing additional treatments like insulin. The study will also check for any side effects and how the infants grow and develop while on the treatment.

Throughout the study, the infants will be closely observed to ensure their safety and well-being. The researchers will look at various factors, such as how the infants' blood sugar levels change, any reactions to the medication, and overall health outcomes. The goal is to gather information that could help improve the care and treatment of premature infants with high blood sugar levels in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves newborns less than 34 weeks post-menstrual age with a birth weight under 1500 grams.

    Eligibility requires a condition called transient hyperglycaemia, which is high blood sugar levels in premature infants.

    Consent from legal guardians is necessary before participation.

  2. Step 2

    Treatment initiation

    The treatment uses AMGLIDIA 6 mg/mL oral suspension, which contains the active substance glibenclamide.

    Glibenclamide is administered through oral, nasogastric, or percutaneous endoscopic gastrostomy tube use.

    The main goal is to control blood sugar levels over a 72-hour period without the use of insulin.

  3. Step 3

    Monitoring and assessment

    Blood sugar levels are monitored to ensure they remain stable without severe or moderate hypoglycaemia.

    The treatment's success is determined by the absence of insulin use and stable blood sugar levels.

    Additional assessments include nutritional intake, growth, and any adverse reactions to the medication.

  4. Step 4

    Completion of treatment

    The treatment duration is evaluated based on the infant's response to glibenclamide.

    The study also observes neonatal health outcomes at 36 weeks post-menstrual age, including any complications or mortality.

Who can join the trial?

8 criteria

  • The newborn must be less than 34 weeks old, based on the time since the mother's last menstrual period.
  • The newborn's birth weight must be less than 1500 grams.
  • The newborn's gestational age, which is the time spent in the womb, must be less than 32 weeks.
  • The newborn must have high blood sugar levels, known as hyperglycaemia, of 10 mmol/l or more. This must be confirmed by two separate blood tests taken at least 3 hours apart, after reducing sugar intake as per the hospital's guidelines. If the tests are not consecutive, they should be within a maximum of 9 hours apart.
  • The newborn must have a secure way to receive fluids or medication through a vein, using either an umbilical venous catheter or an epicutaneo-cava catheter.
  • The newborn must be able to receive food through the digestive system, or this process should have already started before joining the study.
  • Consent must be obtained from the newborn's legal guardians.
  • The newborn must be covered by social security.

Who cannot join the trial?

6 criteria

  • Infants who weigh more than 1500 grams cannot participate.
  • Infants who do not have **transient hyperglycaemia** cannot participate. This means their blood sugar levels are not temporarily high.
  • Infants who are not premature cannot participate. Premature means they were born before the usual time.
  • Infants who are not able to take the medication by mouth cannot participate.
  • Infants with any other serious health conditions that might interfere with the study cannot participate.
  • Infants who are part of another clinical trial cannot participate.
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Investigated drugs

Glibenclamide is being studied in this trial as an oral medication to help control high blood sugar levels in premature infants. The trial aims to see how effective this medication is over a 72-hour period. It is given in the form of a liquid suspension that the infants can take by mouth. The focus is on infants who are born prematurely and weigh less than 1500 grams, as they are at risk of experiencing temporary high blood sugar levels.

What is already known about the treatment

Glibenclamide – This medication is administered orally in the form of an enteral suspension. It is currently being studied in clinical trials for its effectiveness in managing transient hyperglycemia in premature infants. The main therapeutic indication is to control high blood sugar levels in these infants, particularly those weighing less than 1500 grams. At the molecular level, glibenclamide works by stimulating the release of insulin from the pancreas, which helps lower blood sugar levels. It is classified pharmacologically as a sulfonylurea, a type of medication commonly used to treat diabetes by increasing insulin production.

Investigated diseases

Transient Hyperglycemia in Premature Infants – This condition occurs when premature infants experience elevated blood sugar levels temporarily. It is often seen in infants born before 37 weeks of gestation, particularly those with low birth weight. The condition arises due to the immature development of the infant's insulin-producing cells, leading to insufficient insulin production. As a result, the infant's body struggles to regulate blood sugar levels effectively. Over time, as the infant's body matures, the ability to produce insulin typically improves, and blood sugar levels stabilize. This condition is usually self-limiting and resolves as the infant grows and develops.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2024-512230-15-00Protocol codeP160916JEstimated enrolment35 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).