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Completed

NCT Number: NCT01998113

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

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)

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Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • RCT
  • GDM
  • 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

Treatment and study plan

Glyburide vs Insulin trials

Drug

Affecting groups 1 and 2

Metformin vs Insulin trials

Drug

Affecting groups 3 and 4

Metformin vs Glyburide trials

Drug

Affecting groups 5 and 6

Primary outcomes

  1. 3rd trimester glycated hemoglobin

    Time frame: 3rd trimester of pregnancy

    mean difference of 3rd trimester glycated hemoglobin

  2. total maternal weight gain

    Time frame: during pregnancy

    mean difference of total maternal weight gain (as defined by the authors)

  3. severe maternal hypoglycemia

    Time frame: from enrollment to delivery

    relative risk of severe maternal hypoglycemia (as defined by the authors)

  4. preeclampsia

    Time frame: during pregnancy or puerperium

    relative risk of preeclampsia (as defined by the authors)

  5. cesarean section

    Time frame: at the end of pregnancy

    relative risk of cesarean section (as defined by the authors)

  6. gestational age at birth

    Time frame: at birth

    mean difference of gestational age at birth (as defined by the authors)

  7. preterm birth

    Time frame: at birth

    relative risk of preterm birth (as defined by the authors)

  8. birthweight

    Time frame: at birth

    mean difference of birthweight (as defined by the authors)

  9. macrosomia

    Time frame: at birth

    relative risk of macrosomia (defined as birthweight >=4000 g)

  10. large-for-gestational age newborn

    Time frame: at birth

    relative risk of large-for-gestational age newborn (as defined by the authors)

  11. small-for-gestational age newborn

    Time frame: at birth

    relative risk of small-for-gestational age newborn (as defined by the authors)

  12. neonatal hypoglycemia

    Time frame: in the neonatal period

    relative risk of neonatal hypoglycemia (as provided by the authors)

  13. perinatal mortality

    Time frame: in the perinatal period

    relative risk of perinatal mortality (as defined by the authors)

  14. insulin treatment

    Time frame: from enrollment to delivery

    relative risk of insulin treatment (for trials comparing metformin vs glyburide)

Secondary outcomes

  1. fasting blood glucose

    Time frame: in the period from enrollment to delivery

    mean difference of fasting blood glucose (as defined by the authors)

  2. postprandial blood glucose

    Time frame: in the period from enrollment to delivery

    mean difference of postprandial blood glucose (as defined by the authors)

  3. maternal weight gain since enrollment

    Time frame: in the period from enrollment to delivery

    mean difference of maternal weight gain since enrollment (as defined by the authors)

  4. pregnancy-induced hypertension

    Time frame: during pregnancy

    relative risk of pregnancy-induced hypertension (as defined by the authors)

  5. induction of labour

    Time frame: at the end of pregnancy

    relative risk of induction of labour (as described by the authors)

  6. cord C peptide

    Time frame: at birth

    mean difference of cord C peptide (as defined by the authors)

  7. cord insulin

    Time frame: at birth

    mean difference of cord insulin (as defined by the authors)

  8. abnormal 1 min Apgar

    Time frame: at birth

    relative risk of abnormal 1 min Apgar (defined as lower than 7)

  9. abnormal 5 min Apgar

    Time frame: at birth

    relative risk of abnormal 5 min Apgar (defined as lower than 7)

  10. obstetric trauma

    Time frame: at birth

    relative risk of obstetric trauma (as defined by the authors)

  11. severe neonatal hypoglycemia

    Time frame: in the neonatal period

    relative risk of severe neonatal hypoglycemia (as defined by the authors)

  12. neonatal jaundice

    Time frame: in the neonatal period

    relative risk of neonatal jaundice (as defined by the authors)

  13. significant respiratory distress

    Time frame: in the neonatal period

    relative risk of significant respiratory distress (described as respiratory distress syndrome or requiring respiratory support)

  14. stillbirth

    Time frame: in the antenatal period

    relative risk of stillbirth (as defined by the authors)

  15. neonatal mortality

    Time frame: in the neonatal period

    relative risk of neonatal mortality (as defined by the authors)

  16. Neonatal Intensive Care Unit (NICU) admittance

    Time frame: in the neonatal period

    relative risk of NICU admittance (as defined by the authors)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 28, 2013
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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