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PMID- 29715355
OWN - NLM
STAT- In-Process
LR  - 20180504
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 319
IP  - 17
DP  - 2018 May 1
TI  - Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among
      Women With Gestational Diabetes: A Randomized Clinical Trial.
PG  - 1773-1780
LID - 10.1001/jama.2018.4072 [doi]
AB  - Importance: Randomized trials have not focused on neonatal complications of
      glyburide for women with gestational diabetes. Objective: To compare oral
      glyburide vs subcutaneous insulin in prevention of perinatal complications in
      newborns of women with gestational diabetes. Design, Settings, and Participants: 
      The Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial
      conducted between May 2012 and November 2016 (end of participant follow-up) in 13
      tertiary care university hospitals in France including 914 women with singleton
      pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of
      gestation. Interventions: Women who required pharmacologic treatment after 10
      days of dietary intervention were randomly assigned to receive glyburide (n=460) 
      or insulin (n=454). The starting dosage for glyburide was 2.5 mg orally once per 
      day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 
      5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d. The
      starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times
      per day as necessary and increased according to self-measured blood glucose
      concentrations. Main Outcomes and Measures: The primary outcome was a composite
      criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia.
      The noninferiority margin was set at 7% based on a 1-sided 97.5% confidence
      interval. Results: Among the 914 patients who were randomized (mean age, 32.8
      [SD, 5.2] years), 98% completed the trial. In a per-protocol analysis, 367 and
      442 women and their neonates were analyzed in the glyburide and insulin groups,
      respectively. The frequency of the primary outcome was 27.6% in the glyburide
      group and 23.4% in the insulin group, a difference of 4.2% (1-sided 97.5% CI,
      -infinity to 10.5%; P=.19). Conclusion and Relevance: This study of women with
      gestational diabetes failed to show that use of glyburide compared with
      subcutaneous insulin does not result in a greater frequency of perinatal
      complications. These findings do not justify the use of glyburide as a first-line
      treatment. Trial Registration: clinicaltrials.gov Identifier: NCT01731431.
FAU - Senat, Marie-Victoire
AU  - Senat MV
AD  - Assistance Publique-Hopitaux de Paris, Department of Gynecology-Obstetrics,
      Bicetre Hospital, Le Kremlin-Bicetre, France.
AD  - University of Paris-Sud, University of Medicine Paris-Saclay, Le Kremlin-Bicetre,
      France.
AD  - Centre for Research in Epidemiology and Population Health, Universite
      Paris-Saclay, Universite Paris-Sud, Universite de Versailles
      Saint-Quentin-en-Yvelines, INSERM, Villejuif, France.
FAU - Affres, Helene
AU  - Affres H
AD  - Assistance Publique-Hopitaux de Paris, Department of Reproductive Endocrinology, 
      Bicetre Hospital, Le Kremlin-Bicetre, France.
FAU - Letourneau, Alexandra
AU  - Letourneau A
AD  - Assistance Publique-Hopitaux de Paris, Department of Gynecology-Obstetrics,
      Beclere Hospital, Clamart, France.
FAU - Coustols-Valat, Magali
AU  - Coustols-Valat M
AD  - Department of Endocrinology-Obstetrics, Toulouse University Hospital, Toulouse,
      France.
FAU - Cazaubiel, Marie
AU  - Cazaubiel M
AD  - Department of Endocrinology, Lille University Hospital EA 4489-Environnement
      Perinatal et Sante, Lille, France.
FAU - Legardeur, Helene
AU  - Legardeur H
AD  - Assistance Publique-Hopitaux de Paris, Department of Gynecology and Obstetrics,
      Hopital Louis Mourier, Colombes, France.
FAU - Jacquier, Julie Fort
AU  - Jacquier JF
AD  - Department of Gynecology-Obstetrics, Poissy St-Germain Hospital, Poissy, France.
FAU - Bourcigaux, Nathalie
AU  - Bourcigaux N
AD  - Assistance Publique-Hopitaux de Paris, Department of Endocrinology, St Antoine
      Hospital Paris, France.
FAU - Simon, Emmanuel
AU  - Simon E
AD  - Department of Obstetrics, Gynecology and Fetal Medicine, University Hospital
      Center of Tours, Tours, France.
FAU - Rod, Anne
AU  - Rod A
AD  - Department of Endocrinology, Caen University Hospital, Caen, France, France.
FAU - Heron, Isabelle
AU  - Heron I
AD  - Department of Endocrinology, Rouen University Hospital-Charles Nicolle, Rouen,
      France.
FAU - Castera, Virginie
AU  - Castera V
AD  - Department of Endocrinology, St Joseph Hospital, Marseille, France.
FAU - Sentilhes, Loic
AU  - Sentilhes L
AD  - Department of Obstetrics and Gynecology, Angers University Hospital, Angers,
      France.
AD  - Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, 
      France.
FAU - Bretelle, Florence
AU  - Bretelle F
AD  - Assistance Publique-Hopitaux de Marseille; AMU, Aix-Marseille Universite,
      Department of Gynecology and Obstetrics, Pole Femme Enfant, Marseille, France.
FAU - Rolland, Catherine
AU  - Rolland C
AD  - Assistance Publique-Hopitaux de Paris, Department of
      Hepato-Enterology-Gastroenteritis, Beclere Hospital, Clamart, France.
FAU - Morin, Mathieu
AU  - Morin M
AD  - Department of Gynecology-Obstetrics, Toulouse University Hospital, Toulouse,
      France.
FAU - Deruelle, Philippe
AU  - Deruelle P
AD  - Department of Gynecology-Obstetrics, Lille University, EA 4489-Environnement
      Perinatal et Sante, Lille, France.
FAU - De Carne, Celine
AU  - De Carne C
AD  - Assistance Publique-Hopitaux de Paris, Department of Gynecology-Obstetrics,
      Trousseau Hospital, Paris, France.
FAU - Maillot, Francois
AU  - Maillot F
AD  - Department of Internal Medicine, Francois-Rabelais University, University
      Hospital Center of Tours, Tours, France.
FAU - Beucher, Gael
AU  - Beucher G
AD  - Department of Gynecology-Obstetrics, Caen University Hospital, Caen, France,
      France.
FAU - Verspyck, Eric
AU  - Verspyck E
AD  - Department of Gynecology and Obstetrics, Rouen University Hospital-Charles
      Nicolle, Rouen, France.
FAU - Desbriere, Raoul
AU  - Desbriere R
AD  - Department of Gynecology-Obstetrics, St Joseph Hospital, Marseille, France.
FAU - Laboureau, Sandrine
AU  - Laboureau S
AD  - Department of Endocrinology, Angers University Hospital, Angers, France.
FAU - Mitanchez, Delphine
AU  - Mitanchez D
AD  - Assistance Publique-Hopitaux de Paris, Sorbonne Universities, University Pierre
      and Marie Curie, University Paris 06, Department of Neonatology, Armand Trousseau
      Hospital, Paris, France.
FAU - Bouyer, Jean
AU  - Bouyer J
AD  - Centre for Research in Epidemiology and Population Health, Universite
      Paris-Saclay, Universite Paris-Sud, Universite de Versailles
      Saint-Quentin-en-Yvelines, INSERM, Villejuif, France.
CN  - Groupe de Recherche en Obstetrique et Gynecologie (GROG)
LA  - eng
SI  - ClinicalTrials.gov/NCT01731431
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
CIN - JAMA. 2018 May 1;319(17 ):1769-1770. PMID: 29715338
EDAT- 2018/05/02 06:00
MHDA- 2018/05/02 06:00
CRDT- 2018/05/02 06:00
PHST- 2018/05/02 06:00 [entrez]
PHST- 2018/05/02 06:00 [pubmed]
PHST- 2018/05/02 06:00 [medline]
AID - 2679942 [pii]
AID - 10.1001/jama.2018.4072 [doi]
PST - ppublish
SO  - JAMA. 2018 May 1;319(17):1773-1780. doi: 10.1001/jama.2018.4072.