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

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

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.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Glyburide,gestational diabetes, maternal complications, neonatal complications.

Insulin, gestational diabetes, maternal complications, neonatal outcomes.

The registry classes the interventions as drug.

More on the Plan

PLAN: Women who present for prenatal care are routinely screened for gestational diabetes (GDM) with a one-hour 50gm oral glucose challenge test (GCT).

This screening occurs at the first prenatal visit if risk factors (marked obesity, prior pregnancy affected by GDM, prior macrosomic infant, glycosuria, strong family history of diabetes) for GDM are identified on intake history.

If no risk factors for GDM are identified or if initial screening is negative, the GCT is administered between 24-28 weeks gestation.

Positive screening tests are followed by a diagnostic oral glucose tolerance test (GTT).

Who Took Part

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Pregnant women over age 18 who fail to achieve adequate glucose control on diet therapy alone.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: women with preexisting diabetes mellitus or diabetic ketoacidosis; hypersensitivity to study medications; fetal anomalies identified on ultrasound prior to initiation of therapy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2004-06 with completion listed for 2009-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Newborn birth weight (time frame: mid study).

It also tracked 6 secondary outcomes, for example Gestational age at delivery, Method of delivery (cesarean, forceps, vacuum, spontaneous), Complications of delivery (shoulder dystocia, birth injury, 4th degree vaginal laceration), Newborn intensive care unit admission, Congenital anomalies of the newborn and Incidence of neonatal metabolic derangement.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.