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Cited by 252Gestational Diabetes Research and ManagementPregnancy and Medication ImpactDiabetes Treatment and Management

Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice

Open access
Hebert, MF, Ma, X, Naraharisetti, SB, Krudys, KM, Umans, JG, Hankins, GDV, Caritis, SN, Miodovnik, M +10 more·2009·Clinical Pharmacology & Therapeutics
DOI 10.1038/clpt.2009.5PMC PMC2684566
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Abstract

Glyburide's pharmacokinetics (PK) and pharmacodynamics have not been studied in women with gestational diabetes mellitus (GDM). The objective of this study was to assess steady-state PK of glyburide, as well as insulin sensitivity, beta-cell responsivity, and overall disposition indices after a mixed-meal tolerance test (MMTT) in women with GDM (n = 40), nonpregnant women with type 2 diabetes mellitus (T2DM) (n = 26), and healthy pregnant women (n = 40, MMTT only). At equivalent doses, glyburide plasma concentrations were approximately 50% lower in pregnant women than in nonpregnant subjects. The average umbilical cord/maternal plasma glyburide concentration ratio at the time of delivery was 0.7 +/- 0.4. Insulin sensitivity was approximately fivefold lower in women with GDM as compared with healthy pregnant women. Despite comparable beta-cell responsivity indices, the average beta-cell function corrected for insulin resistance was more than 3.5-fold lower in women with glyburide-treated GDM than in healthy pregnant women. Women with GDM in whom glyburide treatment has failed may benefit from alternative medication or dosage escalation; however, fetal safety should be kept in mind.

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Crossref · 10.1038/clpt.2009.5

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51 of 51 references verified0 citation errors · 0 not checkable

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  • Glyburide and metformin failed to provide adequate glycemic outcomes in 23% and 25-28% of participants with GDM, respectively.

    “Furthermore, in separate RCTs, glyburide and metformin failed to provide adequate glycemic outcomes in 23% and 25-28% of participants with GDM, respectively (76,77).”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [76]

    The Discussion says some women with GDM may not achieve glycemic control with glyburide alone. It does not report a 23% failure rate or describe its glyburide study as an RCT. Its mention of a metformin trial concerns perinatal complications, not a 25–28% glycemic failure rate; no page numbers are available in our copy. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • Sulfonylureas are known to cross the placenta and have been associated with increased neonatal hypoglycemia.

    “Sulfonylureas are known to cross the placenta and have been associated with increased neonatal hypoglycemia.”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [76]

    The Discussion reports that glyburide, a sulfonylurea, crossed the placenta: umbilical cord concentrations averaged 70% of maternal concentrations. It does not report an association between sulfonylureas and increased neonatal hypoglycemia; its discussion of hypoglycemia concerns the risk of tighter maternal glucose control. No page number is available in our copy. (LLM, conf=0.87)

    Experimental — accuracy not yet measured

  • Concentrations of glyburide in umbilical cord plasma are approximately 50-70% of maternal levels.

    “Concentrations of glyburide in umbilical cord plasma are approximately 50-70% of maternal levels (76,77).”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [76]

  • In pregnant women taking glyburide, the umbilical cord glyburide concentration is undetectable or, at most, very low.

    “In pregnant women taking glyburide, the umbilical cord glyburide concentration is undetectable (90, 173–176) or, at most, very low (177).”

    From Diabetes and Pregnancy: An Endocrine Society Clinical Practice Guideline (2013) · cites this paper as [177]

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1 of the 52 references couldn’t be matched to a known paper.

Research works printed but not linked: 1

  1. [16]Niemi M Cascorbi I Timm R Kroemer HK Neuvonen PJ Kivisto KT Glyburide and glimepiride pharmacokinetics in subjects with different CYP2C9 genotypes Clin Pharmacol Ther 78 90 92 2005 12235454

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Authors
Hebert, M., Ma, X., Naraharisetti, S., Krudys, K., Umans, J., Hankins, G., Caritis, S., Miodovnik, M., Mattison, D., Unadkat, J., Kelly, E., Blough, D., Cobelli, C., Ahmed, M., Snodgrass, W., Carr, D., Easterling, T., & Vicini, P.
Affiliations
  • University of Washington (US)
  • The University of Texas Medical Branch at Galveston (US)
  • MedStar Washington Hospital Center (US)
  • University of Padua (IT)
  • Pfizer (United States) (US)
ORCID
Venue
Clinical Pharmacology & Therapeutics
Publisher
Wiley
Published
2009-03-18
Volume
85
Issue
6
Pages
607-614
ISSN
  • 0009-9236 (ISSN-L)
  • 1532-6535
DOI
10.1038/clpt.2009.5
PMC
PMC2684566
OpenAlex
W1964571629
Cited by
252
References
52
Citations by year
2026: 5 · 2025: 11 · 2024: 8 · 2023: 11 · 2022: 9 · 2021: 32 · 2020: 12 · 2019: 13 · 2018: 16 · 2017: 13 · 2016: 12 · 2015: 21 · 2014: 19 · 2013: 18 · 2012: 16
FWCI
19.52
Type
journal article
Language
en
Open access
Locations
  • Clinical Pharmacology & Therapeutics (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • Pfizer
  • University of Pittsburgh
  • National Institutes of Health (UL1TR000423, UL1TR000005)
  • National Institute of Biomedical Imaging and Bioengineering (P41EB001975)
  • National Center for Research Resources (M01RR023942, M01-RR 00037, UL1RR025014, M01RR020359, M01RR000037)
  • National Center for Advancing Translational Sciences
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD047891, U10HD047892, U10HD047890, U10HD047905)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
gestational diabetes mellitus, glibenclamide, pharmacokinetics, insulin sensitivity, beta-cell function, insulin resistance, mixed meal tolerance test, type 2 diabetes, dose escalation, fetal safety
MeSH terms
Adult, Aryl Hydrocarbon Hydroxylases, Blood Glucose, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Female, Fetal Blood, Glyburide, Humans, Hypoglycemic Agents, Insulin Resistance, Metabolic Clearance Rate, Monte Carlo Method, Pregnancy, Pregnancy Trimester, Third, Diabetes, Gestational, Area Under Curve, Insulin-Secreting Cells, Cytochrome P-450 CYP2C9

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