Glyburide Compared to Insulin in the Management of White's Classification A2 Gestational Diabetes

• Status: Withdrawn
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tripler Army Medical Center
• Treatments: Glyburide; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Pregnant women over age 18 who fail to achieve adequate glucose control on diet therapy alone.

Exclusion Criteria:

• Delivery planned at other than a participating medical treatment facility.

• Women with preexisting diabetes mellitus or diabetic ketoacidosis.

• Hypersensitivity to study medications

• Underlying vascular disease or medical condition known to affect fetal growth or drug clearance such as: severe chronic hypertension, systemic lupus erythematosis, chronic renal insufficiency, hepatic disease, antiphospholipid antibody syndrome or thrombophilia.

• Fetal anomalies identified on ultrasound prior to initiation of therapy.

• Fetal aneuploidy.

• Diagnosis of GDM made after 32 weeks gestation (fetal growth pattern may be impossible to affect after this gestational age.)

• Use of supplemental herbal/nutraceuticals containing chromium, garlic, gymnema (may cause hypoglycemia).