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Could a sugar pill replace insulin shots for tiny preemies?

NCT ID NCT05687500

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether an oral liquid form of glibenclamide can safely control high blood sugar in very premature infants (born before 32 weeks, weighing under 1.5 kg). The goal is to see if it can replace insulin injections. The trial involves 35 babies and monitors blood sugar control over 72 hours, watching for side effects like severe low blood sugar.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
glibenclamide (oral suspension)
What this could lead to
If successful, this could offer a simpler, oral alternative to insulin for managing high blood sugar in premature babies.
What could go wrong
This is a small, early-phase trial with only 35 infants. The drug may not control blood sugar well enough, or could cause dangerously low blood sugar.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

May 2023

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 34 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypoglycemia Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glibenclamide adverse reaction Preterm Transient; hypoglycemia, neonatal

Contacts and locations

Locations

  • Hopital Necker - Enfants malades

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.