Glyburide Compared to Insulin in the Management of White's Classification A2 Gestational Diabetes
Status:
Withdrawn
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine whether the oral administration of glyburide is as
effective as insulin in the treatment of gestational diabetes.
1. SYNOPSIS: Infants born to mothers with gestational diabetes(GDM) are at risk for a
variety of adverse perinatal outcomes including macrosomia with subsequent birth trauma
and cesarean delivery, neonatal hypoglycemia, polycythemia, jaundice, hypocalcemia,
respiratory depression and newborn intensive care unit admission. These adverse outcomes
are thought to be related to the degree of maternal hyperglycemia during pregnancy.
Women with GDM are typically treated with insulin to lower blood glucose levels to as
near-normal as possible. A single randomized trial has suggested that the oral
sulfonylurea, glyburide is a clinically effective and safe alternative to insulin
therapy.
2. Many obstetric care providers have adopted the use of glyburide in the routine
management of gestational diabetes. The American College of Obstetrics and Gynecology
and the American Diabetic Association both state that further studies are needed in a
larger patient population before the use of newer oral hypoglycemic agents can be
supported for use in pregnancy.
3. STATUS: Previous studies have demonstrated that there is no maternal-fetal transfer of
glyburide and when compared to insulin is an effective alternative to insulin.
Additionally, a published cost analysis concluded that glyburide is significantly less
costly than insulin for the treatment of GDM. The benefits of an oral agent for the
management of gestational diabetes include less discomfort for the patient in drug
administration, lower requirement for patient education in the administration of
injectable medications and less chance of error in dosing. Our study population is more
ethnically diverse and our incidence of large for gestational age infants is lower than
in the largely Hispanic population studied by Langer et al. Many obstetricians,
including ourselves, apply different criteria than Langer for diagnosing gestational
diabetes , and for deciding when to institute insulin therapy. It is our goal to confirm
the prior single study concerning the safety and efficacy of glyburide in reducing the
complications of GDM utilizing a more ethnically diverse population with more realistic
goals in glycemic control. To this end we will add to the medical literature supporting
this alternative therapy to insulin.