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

NCT00160485 | Withdrawn Phase 4 DMC

• 1 other identifier: TAMC 16H04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes; Pregnancy; Glyburide; Insulin

Outcome Measures

Primary Outcomes (1)

• Newborn birth weight

  mid study

Secondary Outcomes (6)

• Gestational age at delivery

  Completion of study

• Method of delivery (cesarean, forceps, vacuum, spontaneous)

  completion of study

• Complications of delivery (shoulder dystocia, birth injury, 4th degree vaginal laceration)

  completion of study

• Newborn intensive care unit admission

  mid study

• Congenital anomalies of the newborn

  completion of study

Study Arms (2)

1

EXPERIMENTAL

Glyburide,gestational diabetes, maternal complications, neonatal complications

Drug: Glyburide

2

ACTIVE COMPARATOR

Insulin, gestational diabetes, maternal complications, neonatal outcomes

Drug: Insulin

Interventions

Glyburide DRUG

dosage required to obtain adequate glucose control

1

Insulin DRUG

variable dosage to obtain glucose control

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tripler Army Medical Center: lead

Study Sites (1)

Tripler Army Medical Center

Honolulu, Hawaii, 97859, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Glyburide; Insulin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Elizabeth G Spooner, MD

  Tripler Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: June 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: February 11, 2014

Record last verified: 2011-07

Locations

US (1)