Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes (INDAO)

This study is currently recruiting participants.
Verified May 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01731431
First received: September 11, 2012
Last updated: January 2, 2014
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Diabetes
Gestational
Other: Insulin
Drug: Glyburide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 900
Study Start Date: January 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin
standard protocol of insulin treatment for gestational diabetes
Other: Insulin
Experimental: Glyburide
initial dose 2.5 mg per day increased if necessary until 10mg twice a day if glycemia is not controlled
Drug: Glyburide

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731431

Contacts
Contact: Marie-Victoire Senat, PhD +33 1 45 21 77 64 marie-victoire.senat@bct-aphp.fr
Contact: Jean Bouyer, PhD +33 1 45 21 20 35 jean.bouyer@inserm.fr

Locations
France
Marie-Victoire Senat Recruiting
Paris, France, 94270
Contact: Laurence BUSSIERES    +33144841779 ext 1779    laurence.bussieres@apr.aphp.fr   
Contact: Shoreh AZIMI    +33144841779 ext 1779    shohreh.azimi@sls.aphp.fr   
Principal Investigator: Marie-Victoire SENAT         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marie-Victoire SENAT, PhD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01731431     History of Changes
Other Study ID Numbers: P110104
Study First Received: September 11, 2012
Last Updated: January 2, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Gestational Diabetes,
Insulin,
Glyburide,
Glycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Glyburide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014