An Early Phase 1 interventional study of Glyburide and Glucovance in Gestational Diabetes, sponsored by Texas Tech University Health Sciences Center, El Paso. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-12.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Early Phase 1, Interventional, and Treatment
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.
842 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's enrollment of 7 is below the median of 110 across 549 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Texas Tech University Health Sciences Center, El Paso is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. * The starting dose of glyburide may be 2.5milligrams (mg) to 5mg every day(QD) or twice daily (BID) depending on the degree of hyperglycemia. * The dose of glyburide will be increased as needed to a maximum of 20mg /day. * Antenatal testing will be initiated at 28 weeks * Patients will receive monthly growth scans
Drug: Glyburide
* Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. * The starting dose of glucovance may be 1.25/250milligrams (mg) either once daily (QD) or twice a day (BID) increased to a maximum of 20mg/2000mg as needed. * Patients will receive monthly growth scans * Antenatal testing will be initiated at 28 weeks.
Drug: Glucovance
glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
Also known as: micronase, diabeta, glynase
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)
Also known as: combination glyburide and metformin
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
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Plan to share: No
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center, El Paso