Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial

Sénat, Marie-Victoire; Affres, Hélène; Letourneau, Alexandra; Coustols-Valat, Magali; Cazaubiel, M.; Legardeur, Hélène; Jacquier, Julie Fort; Bourcigaux, Nathalie; Simon, Emmanuel; Rod, A.; Héron, Isabelle; Castera, V.; Sentilhes, Loïc; Bretelle, Florence; Rolland, Catherine; Morin, Mathieu; Deruelle, Philippe; Carné, C. De; Maillot, F.; Beucher, G.; Verspyck, É.; Desbrière, Raoul; Laboureau, S.; Mitanchez, Delphine; Bouyer, Jean

doi:10.1097/01.ogx.0000546165.11544.9d

Cited by 13 publications

(31 citation statements)

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“…More recently, glyburide failed to be found noninferior to insulin based on a composite outcome of neonatal hypoglycemia, macrosomia, and hyperbilirubinemia. Long-term safety data for offspring are not available (47,48).…”

Section: Sulfonylureasmentioning

confidence: 99%

14. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes—2019

2018

Diabetes Care

234

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The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

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Section: Sulfonylureasmentioning

confidence: 99%

14. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes—2019

2018

Diabetes Care

234

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“…For the SUGAR-DIP trial, we have set the upper limit for inclusion to 34 weeks, in line with previous trials,22 23 40 allowing at least 4 weeks of exposure to pharmacological treatment. With the timing of the OGTT in current guidelines, it is expected that the majority of women will be treated for over 8 weeks.…”

Section: Methodsmentioning

confidence: 99%

SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

et al. 2019

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IntroductionIn women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.MethodsThe SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.Trial registration numberNTR6134; Pre-results.

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“…Maternal disorder of glucose metabolism probably affected maternal-neonatal health and metabolism during pregnancy [1,2]. Meanwhile, on the basis of the International Association of Diabetes and Pregnancy Study Groups (IADPSG), over 17% of pregnant women would be diagnosed with gestational diabetes mellitus [3].…”

Section: Introductionmentioning

confidence: 99%

Neonatal Hypoglycemia Related to Glycine Levels in Uncontrolled Gestational Diabetes Mellitus during Mid-Late Pregnancy: Multicenter, Prospective Case-Cohort Observational Study

Long

Chen

Yang

et al. 2020

Journal of Diabetes Research

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Aims. To explore the relationship between gestational diabetes mellitus (GDM) and neonatal cord blood amino acid and carnitine levels after GDM was diagnosed among pregnant women monitoring glycosylated haemoglobin levels of 5.5%-6.4% during mid-late gestation. Methods. In all, 7289 qualified participants were recruited and divided into two groups (GDM and control groups) between 1 July 2015 and 1 July 2020, and all maternal-neonatal data were collected and analyzed at three centers. Results. Interestingly, glycine in cord blood was not only significantly different between groups (15.52 vs. 6.67, P < 0.001 ) but also associated with neonatal hypoglycemia ( r = 0.132 , P < 0.001 ). Although glycine was an independent positive factor with neonatal hypoglycemia, it had lacked effective size to predict the risk of neonatal hypoglycemia ( b = 0.002 , P < 0.001 ). Conclusion. The study identifies some differences and relationships in maternal-neonatal data when the GDM group has fluctuating glycosylated haemoglobin levels of 5.5%-6.4% without hypoglycemic drug intervention, compared with the control group. Although umbilical cord blood of glycine levels has a lack of effective power to predict the risk of neonatal hypoglycemia, it is probably an independent factor involved in the maternal-neonatal glucolipid metabolism.

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Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial

Cited by 13 publications

References 0 publications

14. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes—2019

14. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes—2019

SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

Neonatal Hypoglycemia Related to Glycine Levels in Uncontrolled Gestational Diabetes Mellitus during Mid-Late Pregnancy: Multicenter, Prospective Case-Cohort Observational Study

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