A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.
This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
glucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID)
TTUHSC El Paso
El Paso, Texas, United States
efficacy of glyburide compared to glucovance
failure rate of glyburide compared to glucovance in ability to achieve euglycemia
Time frame: during the index pregnancy
maternal hypoglycemia
the rate of maternal hypoglycemia associated with each drug
Time frame: during the index pregnancy
neonatal birthweight
infant weight at birth
Time frame: at birth
neonatal apgar scores
infant 1 minute and 5 minute apgar scores
Time frame: at birth
neonatal admission to the newborn intensive care unit (NICU)
admission to the Newborn intensive care unit (NICU)
Time frame: at birth or within the first 24 hours after birth
neonatal hypoglycemia
failure of the neonate to maintain blood glucose \> 60 milligrams/deciliter (mg/dl)
Time frame: up to 24 hours after delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.