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- Title
Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial.
- Authors
Sénat, Marie-Victoire; Affres, Helene; Letourneau, Alexandra; Coustols-Valat, Magali; Cazaubiel, Marie; Legardeur, Helene; Jacquier, Julie Fort; Bourcigaux, Nathalie; Simon, Emmanuel; Rod, Anne; Héron, Isabelle; Castera, Virginie; Sentilhes, Loic; Bretelle, Florence; Rolland, Catherine; Morin, Mathieu; Deruelle, Philippe; De Carne, Celine; Maillot, François; Beucher, Gael
- Abstract
<bold>Importance: </bold>Randomized trials have not focused on neonatal complications of glyburide for women with gestational diabetes.<bold>Objective: </bold>To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes.<bold>Design, Settings, and Participants: </bold>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.<bold>Interventions: </bold>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.<bold>Main Outcomes and Measures: </bold>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.<bold>Results: </bold>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, -∞ to 10.5%; P=.19).<bold>Conclusion and Relevance: </bold>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.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT01731431.
- Subjects
GESTATIONAL diabetes; INSULIN; ALTERNATIVE treatment for diabetes; MATERNAL health services; DRUG therapy; THERAPEUTICS; BLOOD sugar analysis; INSULIN therapy; SUBCUTANEOUS injections; COMPARATIVE studies; HYPERBILIRUBINEMIA; HYPOGLYCEMIA; HYPOGLYCEMIC agents; HYPOGLYCEMIC sulfonylureas; NEONATAL diseases; RESEARCH methodology; EVALUATION of medical care; MEDICAL cooperation; ORAL drug administration; PREGNANCY; RESEARCH; STATISTICAL sampling; EVALUATION research; RANDOMIZED controlled trials; FETAL macrosomia; PREVENTION
- Publication
JAMA: Journal of the American Medical Association, 2018, Vol 319, Issue 17, p1773
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2018.4072