Gestational Diabetes
Conditions
Keywords
gestational diabetes, pregnancy, diabetes
Brief summary
A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.
Detailed description
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.
Interventions
DRUGGlyburide
glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
DRUGGlucovance
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)
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Gestational diabetes * Pregnancy \> 12 weeks gestation * Ability to give consent
Exclusion criteria
* Inability to consent to the study * Pre-existing diabetes * Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Serum creatinine \>1 * Liver disease * Allergy to sulfa; * Allergy to glyburide; * Allergy to metformin; * Fetal anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of glyburide compared to glucovance | during the index pregnancy | failure rate of glyburide compared to glucovance in ability to achieve euglycemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maternal hypoglycemia | during the index pregnancy | the rate of maternal hypoglycemia associated with each drug |
| neonatal birthweight | at birth | infant weight at birth |
| neonatal apgar scores | at birth | infant 1 minute and 5 minute apgar scores |
| neonatal admission to the newborn intensive care unit (NICU) | at birth or within the first 24 hours after birth | admission to the Newborn intensive care unit (NICU) |
| neonatal hypoglycemia | up to 24 hours after delivery | failure of the neonate to maintain blood glucose \> 60 milligrams/deciliter (mg/dl) |
Countries
United States
Outcome results
None listed