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Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. Systematic Review

Information source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gestational Diabetes Mellitus

Intervention: Glyburide vs Insulin trials (Drug); Metformin vs Insulin trials (Drug); Metformin vs Glyburide trials (Drug)

Phase: N/A

Status: Completed

Sponsored by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau


Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM), additional studies of oral agents for the treatment of GDM have been published (observational, randomized controlled trials (RCT), and trials using other drugs like metformin). Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing metformin vs insulin). Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. Specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. This information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)

Clinical Details

Official title: Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other.

Study design: Time Perspective: Retrospective

Primary outcome:

3rd trimester glycated hemoglobin

total maternal weight gain

severe maternal hypoglycemia


cesarean section

gestational age at birth

preterm birth



large-for-gestational age newborn

small-for-gestational age newborn

neonatal hypoglycemia

perinatal mortality

insulin treatment

Secondary outcome:

fasting blood glucose

postprandial blood glucose

maternal weight gain since enrollment

pregnancy-induced hypertension

induction of labour

cord C peptide

cord insulin

abnormal 1 min Apgar

abnormal 5 min Apgar

obstetric trauma

severe neonatal hypoglycemia

neonatal jaundice

significant respiratory distress


neonatal mortality

Neonatal Intensive Care Unit (NICU) admittance

Detailed description: This project involves the systematic review of RCT addressing the use of glyburide or metformin for the treatment of GDM. The review will include RCT comparing these drugs versus insulin or making direct comparisons between the two oral agents in pregnant women with GDM. Investigators have pre-specified a series of maternal and fetal outcomes of interest. A comprehensive electronic search strategy will be complemented with a search of bibliographies from relevant studies and the contact of authors from the eligible studies regarding issues on study design or information on primary outcomes. The risk of bias of included studies will be analyzed and this information used to perform sensitivity analyses. If possible, data from original studies will be pooled into relative risks for dichotomous outcomes and mean differences for continuous outcomes. Heterogeneity will be explored for all the analyses. Analyses will be undertaken using a fixed effects model that will be repeated using a random effects model in case of substantial heterogeneity. Results of the systematic review will be published following PRISMA guidance.


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:



- comparing Glyburide vs Insulin, Metformin vs Insulin or Metformin vs Glyburide

- data on fetal and/or maternal outcomes

- full text available

Exclusion Criteria:

- significant overlap with other articles of the same group

Locations and Contacts

Hospital de la Santa Creu i Sant Pau, Barcelona 08025, Spain
Additional Information

Related publications:

Langer O, Conway DL, Berkus MD, Xenakis EM, Gonzales O. A comparison of glyburide and insulin in women with gestational diabetes mellitus. N Engl J Med. 2000 Oct 19;343(16):1134-8.

Rowan JA, Hague WM, Gao W, Battin MR, Moore MP; MiG Trial Investigators. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med. 2008 May 8;358(19):2003-15. doi: 10.1056/NEJMoa0707193. Erratum in: N Engl J Med. 2008 Jul 3;359(1):106.

Dhulkotia JS, Ola B, Fraser R, Farrell T. Oral hypoglycemic agents vs insulin in management of gestational diabetes: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Nov;203(5):457.e1-9. doi: 10.1016/j.ajog.2010.06.044. Epub 2010 Aug 24. Review.

Nicholson W, Bolen S, Witkop CT, Neale D, Wilson L, Bass E. Benefits and risks of oral diabetes agents compared with insulin in women with gestational diabetes: a systematic review. Obstet Gynecol. 2009 Jan;113(1):193-205. doi: 10.1097/AOG.0b013e318190a459. Review.

Gui J, Liu Q, Feng L. Metformin vs insulin in the management of gestational diabetes: a meta-analysis. PLoS One. 2013 May 27;8(5):e64585. doi: 10.1371/journal.pone.0064585. Print 2013.

Silva JC, Fachin DR, Coral ML, Bertini AM. Perinatal impact of the use of metformin and glyburide for the treatment of gestational diabetes mellitus. J Perinat Med. 2012 Jan 10;40(3):225-8. doi: 10.1515/jpm-2011-0175.

Starting date: March 2013
Last updated: March 23, 2015

Page last updated: August 23, 2015

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