Dataset Information

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

ABSTRACT:

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, -∞ 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.

SUBMITTER: Senat MV

PROVIDER: S-EPMC6583037 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:OBJECTIVES: To assess the maternal and fetal complications of pregnancy in mothers with gestational diabetes mellitus (GDM) compared with non-diabetic patients who delivered in the hospital during the study period. METHODS: The outcome of pregnancy in 220 Saudi patients with GDM identified from the delivery register/hospital database and matched for age, parity and body mass index with 220 non-diabetic controls were studied retrospectively from their case files. Patients with multiple pregnancies and abnormal presentation of the fetus were excluded from the study. RESULTS: The GDM patients were treated with either diet alone or with additional insulin in some patients who required better control of their blood sugar levels. Patients with GDM had a significantly higher incidence of pre-eclampsia (p<0.0001); preterm delivery (p=0.0226); induction of labor (p<0.0001); cesarean section (p=0.0019); higher mean birth weight (p<0.0001) of babies; large for gestational age infants (p=0.0011); macrosomia (p=0.0186); and admission to the neonatal intensive care unit (p=0.0003), compared with the control group. However, the rates of Apgar score <7 at 5 minutes, respiratory distress syndrome, neonatal hypoglycemia, hyperbilirubinemia and the need for phototherapy were similar in both groups of patients. Congenital anomalies and perinatal mortality rates were not significantly different in the two groups. CONCLUSION: GDM is recognized to be associated with increased rates of adverse maternal and neonatal outcomes, which are supported by the findings of this study. Even the mild form of GDM seems to have significant consequences for women and their offspring and is recommended to be aggressively treated. Evidence suggests that early diagnosis and strict control of blood sugar levels throughout the pregnancy can significantly reduce maternal and fetal complications. A multicenter, randomized controlled trial, based on universally accepted criteria for GDM screening test, standardized diagnostic OGTT and management of all patients with GDM versus the standard obstetric management of the control is warranted.

Project description:To describe trends and identify factors associated with choice of pharmacotherapy for gestational diabetes (GDM) from 2000-2011 using a healthcare claims database.This was a retrospective cohort study of a large nationwide population of commercially insured women with GDM and pharmacy claims for glyburide or insulin before delivery, 2000-2011. We excluded women younger than 15 years or older than 50 years, those with prior noninsulin-dependent diabetes mellitus, or those who had multiple gestations. We estimated trends over time in the use of glyburide compared with insulin and prevalence ratios and 95% confidence intervals (CIs) for the association between covariates of interest and treatment with glyburide compared with insulin.We identified 10,778 women with GDM treated with glyburide (n=5,873) or insulin (n=4,905). From 2000 to 2011, glyburide use increased from 7.4% to 64.5%, becoming the more common treatment in 2007. Women less likely to be treated with glyburide were those with metabolic syndrome (prevalence ratio 0.71, 95% CI 0.50-0.99), hyperandrogenism (prevalence ratio 0.77, 95% CI 0.62-0.97), polycystic ovarian syndrome (prevalence ratio 0.88, 95% CI 0.78-0.99), hypothyroidism (prevalence ratio 0.89, 95% CI 0.83-0.96), or undergoing infertility treatment (prevalence ratio 0.93, 95% CI 0.86-1.02). The probability of receiving glyburide decreased by 5% for every 10-year increase in maternal age (prevalence ratio 0.95, 95% CI 0.91-0.99). Among women prescribed with glyburide, 7.8% switched or augmented to a different drug class compared with 1.1% of insulin initiators.Glyburide has replaced insulin as the more common pharmacotherapy for GDM over the past decade among those privately insured. Given its rapid uptake and the potential implications of suboptimal glucose control on maternal and neonatal health, robust evaluation of glyburide's relative effectiveness is warranted to inform treatment decisions for women with gestational diabetes.II.