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Pill vs. shot: can glyburide replace insulin for gestational diabetes?

NCT ID NCT01731431

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 large study tested whether the diabetes pill glyburide works as well as insulin shots for treating gestational diabetes in 914 pregnant women. The goal was to see if glyburide could prevent newborn complications like high birth weight, low blood sugar, and jaundice. If effective, it could offer a more convenient treatment option.

What this could mean

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

Active substance
Glyburide (a pill to lower blood sugar)
What this could lead to
If glyburide works as well as insulin, it could offer a simpler, pill-based option for managing gestational diabetes, reducing the need for injections.
What could go wrong
This trial is complete, but results may not apply to all pregnant women. Glyburide might not control blood sugar as effectively as insulin in some cases, and side effects like low blood sugar are possible.

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

914 people

The number who actually took part.

Started

May 2012

Finished

Jun 2017

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

18 to 45 years

Sex

Female participants only

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: * gestational diabetes diagnosed between 24 and 34 weeks according to international criteria. Exclusion Criteria: * Multiple Pregnancy * Chronic Hypertension * Preeclampsia * Renal impairment * Hepatic insufficiency * Long time corticosteroids treatment * Allergy to sulfa drugs * Pre-existing diabetes in pregnancy * Abnormal result on screening test for gestational diabetes before 24SA * Fasting glucose ≥ 1.26 g / l at initial diagnosis of diabetes * The need for drug treatment contraindicated or not recommended with taking Glibenclamide * Poor understanding of French * Lack of Social Insurance

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gestational diabetes Insulin Resistance

As listed by the trial registrant

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

Diabetes Gestational

Contacts and locations

Locations

  • Marie-Victoire Senat

    Paris, 94270, France

More trials for these conditions

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