NCT01731431

Brief Summary

This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the treatment of gestational diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
914

participants targeted

Target at P75+ for phase_3 diabetes

Timeline
Completed

Started May 2012

Longer than P75 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2017

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

4.8 years

First QC Date

September 11, 2012

Last Update Submit

August 29, 2025

Conditions

DiabetesGestational

Keywords

Gestational Diabetes,Insulin,Glyburide,Glycemia

Outcome Measures

Primary Outcomes (1)

  • Composite criterion of neonatal complications associated with gestational diabetes: macrosomia or birth weight ≥ 90th percentile for gestational age, neonatal hypoglycemia and neonatal hyperbilirubinemia

    At birth until neonatal discharge from maternity

Secondary Outcomes (1)

  • Rates of caesarean section, preterm delivery rate, neonatal mortality rate, number of neonatal and maternal trauma related to delivery, number of respiratory distress, number of prenatal visits, number of days of hospitalization

    during pregnancy until maternal discharge from maternity

Study Arms (2)

Insulin

ACTIVE COMPARATOR

standard protocol of insulin treatment for gestational diabetes

Other: Insulin

Glyburide

EXPERIMENTAL

initial dose 2.5 mg per day increased if necessary until 10mg twice a day if glycemia is not controlled

Drug: Glyburide

Interventions

InsulinOTHER
Insulin
GlyburideDRUG
Glyburide

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • gestational diabetes diagnosed between 24 and 34 weeks according to international criteria.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie-Victoire Senat

Paris, 94270, France

Location

Related Publications (1)

  • Senat MV, Affres H, Letourneau A, Coustols-Valat M, Cazaubiel M, Legardeur H, Jacquier JF, Bourcigaux N, Simon E, Rod A, Heron I, Castera V, Sentilhes L, Bretelle F, Rolland C, Morin M, Deruelle P, De Carne C, Maillot F, Beucher G, Verspyck E, Desbriere R, Laboureau S, Mitanchez D, Bouyer J; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1773-1780. doi: 10.1001/jama.2018.4072.

    PMID: 29715355BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusDiabetes, GestationalInsulin Resistance

Interventions

InsulinGlyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsSulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Marie-Victoire SENAT, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2012

First Posted

November 21, 2012

Study Start

May 18, 2012

Primary Completion

March 15, 2017

Study Completion

June 2, 2017

Last Updated

September 5, 2025

Record last verified: 2025-08

Locations

FR(1)