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Pill may free babies with rare diabetes from daily insulin shots

NCT ID NCT00610038

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether babies with a rare, permanent form of diabetes caused by specific gene changes could switch from daily insulin injections to an oral pill called glibenclamide. Nineteen infants took part. The goal was to see if the pill could control their blood sugar and possibly improve their development, while avoiding the need for lifelong insulin.

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

19 people

The number who actually took part.

Start date

Jul 2006

Finished

Dec 2011

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * coding sequence of KCNJ11 or ABCC8 in patients having a permanent neonatal diabetes mellitus * written informed consent Exclusion Criteria: * hypersensibility of sulfonylureas * severe renal failure (clearance of creatinemia \< 30 ml/min) * severe hepatic failure (Prothrombin rate \< 70 %) * Porphyria * imidazol treatments * pregnancy * no social security affiliation

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Conditions

The condition(s) this trial relates to.

diabetes mellitus permanent neonatal diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus

Contacts and locations

Locations

  • Necker Hospital - Endocrinology Gynecology Pediatric unit

    Paris, 75015, France

More trials for these conditions

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