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Easier diabetes meds for kids? liquid glibenclamide trial shows promise

NCT ID NCT02375828

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new liquid version of the diabetes drug glibenclamide in 10 children with neonatal diabetes. The goal was to see if the liquid form is easier to take and as safe as the standard pills. Children first took the pill form for one month, then switched to the liquid for four months. Researchers measured how well the liquid was accepted and any side effects.

What this could mean

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

Active substance
glibenclamide (a diabetes drug)
What this could lead to
If successful, this could provide a more child-friendly liquid version of glibenclamide, making it easier for infants and young children with neonatal diabetes to take their daily medication.
What could go wrong
This is a small, completed trial with only 10 participants, so results may not apply to all children. The study focuses on ease of use and safety, not on curing the disease.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

10 people

The number who actually took part.

Started

Mar 2015

Finished

Jul 2019

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

1 month to 18 years

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: * Age below 18 years * Neonatal diabetes secondary to documented mutation in one of the 2 sub units of potassium channels * Patients already treated by glibenclamide pills * Signed consent Exclusion Criteria: * Families unable to fill in the questionnaries * Patients unable to answer to the visual hedonic squale * Patients unable to take the oral solution * Known allergy to sulfonylureas or to other antidiabetic or antibiotic sulfamides * Insulin therapy associated to glibenclamide * Miconazole therapy * Porphyria * Breast feeding * Severe renal failure (creatinine clearance below 30 ml/mn) * Liver failure (prothombine time below 70) * Not affiliated to the health care system

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Conditions

The condition(s) this trial relates to.

neonatal diabetes mellitus

As listed by the trial registrant

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

Neonatal diabetes secondary to mutation in the potassium channel

Contacts and locations

Locations

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 7501, France