DiabetesPhase 3INDAONCT01731431
Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes
A Phase 3 study testing Insulin and Glyburide in people with Diabetes and Gestational, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the treatment of gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- Insulin and Glyburide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 914 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2012to 2 Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- gestational diabetes diagnosed between 24 and 34 weeks according to international criteria.
Who cannot join
- Multiple Pregnancy
- Chronic Hypertension
- Preeclampsia
- Renal impairment
- Hepatic insufficiency
- Long time corticosteroids treatment
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the treatment of gestational diabetes.
Read the detailed description
In patients with gestational diabetes, a therapeutic treatment with a diet, a blood glucose monitoring and, if necessary, treatment with insulin is associated with reduced neonatal complications. Although the effectiveness of insulin is proven, this therapy has many drawbacks, especially in terms of implementation and monitoring by women. An alternative is the use of oral antidiabetic agents like glibenclamide.
Assumption: Glibenclamide is non-inferior to insulin for the treatment of gestational diabetes.
Main objective: To test the oral Glibenclamide is non-inferior to subcutaneous insulin for the occurrence of perinatal complications in the management of pregnant women developing gestational diabetes and requiring treatment other than dietary.
Secondary Objective: To test the noninferiority of two treatments on maternal glycemic control and maternal complications.
Sample size: With a 80% power and a significance level of 5%, 450 subjects per group are required to show that treatment with glibenclamide is not considered inferior to treatment with insulin if the frequency of outcome composite does not exceed 25% with glibenclamide, whereas it was 18% with insulin (calculated with a non-inferiority margin of 7% and considering that 20% of patients treated with glyburide and Insulin for change half of the patients accept randomization).
Progress of the study: Inclusion of women between 24 and 34 weeks. Randomization between Insulin and Glibenclamide after failure of 10 days of dietary treatment well done. Failure defined by at least 2 abnormal values of glycemia: fasting glucose ≥ 0.95 g / l and/or a postprandial 2h ≥ 1.20 g / l.
Women will receive either insulin according to the usual protocol or Glibenclamide at an initial dose of 2.5 mg / once daily in the morning before breakfast. So long as the glycemic targets will not be reached doses are gradually increased stepwise every 4 days until day 21 (20mg/j) . Patients who have not reached the glycemic targets at this highest dose will have a change in treatment for insulin at day 21. Routine monitoring of pregnant women with gestational diabetes, up to a week after delivery Number of clinical sites: 15 Perspective: Use of Glibenclamide as a first line treatment of gestational diabetes requiring drug treatment.
- Conditions
- Diabetes, Gestational
- Being tested
- Insulin, Glyburide
- Keywords
- Gestational Diabetes,, Insulin,, Glyburide,, Glycemia
- Medical subject headings
- Diabetes Mellitus, Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinOther
GlyburideDrug
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Active comparator | standard protocol of insulin treatment for gestational diabetes Receives: Other: Insulin |
| Glyburide | Experimental | initial dose 2.5 mg per day increased if necessary until 10mg twice a day if glycemia is not controlled Receives: Drug: Glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criterion of neonatal complications associated with gestational diabetes: macrosomia or birth weight ≥ 90th percentile for gestational age, neonatal hypoglycemia and neonatal hyperbilirubinemia
Measured: 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
Maternal glycemic control, 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 and maternal satisfaction
Measured: during pregnancy until maternal discharge from maternity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study start18 May 2012
- Primary completion15 Mar 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie-Victoire SENAT, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731431
- Sponsor's protocol ID
- P110104
- Acronym
- INDAO
- Status last verified
- Aug 2025
- First submitted
- 11 Sep 2012
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29715355
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01731431
- Acronym / sponsor ID
- INDAO / P110104
- Conditions
- Diabetes, Gestational
- Keywords
- Gestational Diabetes,, Insulin,, Glyburide,, Glycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 18 May 2012 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the treatment of gestational diabetes.
Detailed description
In patients with gestational diabetes, a therapeutic treatment with a diet, a blood glucose monitoring and, if necessary, treatment with insulin is associated with reduced neonatal complications. Although the effectiveness of insulin is proven, this therapy has many drawbacks, especially in terms of implementation and monitoring by women. An alternative is the use of oral antidiabetic agents like glibenclamide.
Assumption: Glibenclamide is non-inferior to insulin for the treatment of gestational diabetes.
Main objective: To test the oral Glibenclamide is non-inferior to subcutaneous insulin for the occurrence of perinatal complications in the management of pregnant women developing gestational diabetes and requiring treatment other than dietary.
Secondary Objective: To test the noninferiority of two treatments on maternal glycemic control and maternal complications.
Sample size: With a 80% power and a significance level of 5%, 450 subjects per group are required to show that treatment with glibenclamide is not considered inferior to treatment with insulin if the frequency of outcome composite does not exceed 25% with glibenclamide, whereas it was 18% with insulin (calculated with a non-inferiority margin of 7% and considering that 20% of patients treated with glyburide and Insulin for change half of the patients accept randomization).
Progress of the study: Inclusion of women between 24 and 34 weeks. Randomization between Insulin and Glibenclamide after failure of 10 days of dietary treatment well done. Failure defined by at least 2 abnormal values of glycemia: fasting glucose ≥ 0.95 g / l and/or a postprandial 2h ≥ 1.20 g / l.
Women will receive either insulin according to the usual protocol or Glibenclamide at an initial dose of 2.5 mg / once daily in the morning before breakfast. So long as the glycemic targets will not be reached doses are gradually increased stepwise every 4 days until day 21 (20mg/j) . Patients who have not reached the glycemic targets at this highest dose will have a change in treatment for insulin at day 21. Routine monitoring of pregnant women with gestational diabetes, up to a week after delivery Number of clinical sites: 15 Perspective: Use of Glibenclamide as a first line treatment of gestational diabetes requiring drug treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | Active comparator | Other: Insulinstandard protocol of insulin treatment for gestational diabetes |
| Glyburide | Experimental | Drug: Glyburideinitial dose 2.5 mg per day increased if necessary until 10mg twice a day if glycemia is not controlled |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- gestational diabetes diagnosed between 24 and 34 weeks according to international criteria.
Key exclusion criteria (13 listed)
- Multiple Pregnancy
- Chronic Hypertension
- Preeclampsia
- Renal impairment
- Hepatic insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin | Other | Insulin |
| Glyburide | Drug | Glyburide |
Primary outcome
Composite criterion of neonatal complications associated with gestational diabetes: macrosomia or birth weight ≥ 90th percentile for gestational age, neonatal hypoglycemia and neonatal hyperbilirubinemia
Time frame: At birth until neonatal discharge from maternity
1 secondary outcome
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
Time frame: during pregnancy until maternal discharge from maternity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 29715355Senat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Victoire SENAT, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin and Glyburide in people with Diabetes and Gestational, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite criterion of neonatal complications associated with gestational diabetes: macrosomia or birth weight ≥ 90th percentile for gestational age, neonatal hypoglycemia and neonatal hyperbilirubinemia (time frame: At birth until neonatal discharge from maternity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01731431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.