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

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

Overview[ - collapse ][ - ]

Purpose	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)
Condition	Gestational Diabetes Mellitus
Intervention	Drug: Glyburide vs Insulin trials Drug: Metformin vs Insulin trials Drug: Metformin vs Glyburide trials
Phase	N/A
Sponsor	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible Party	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier	NCT01998113
First Received	November 8, 2013
Last Updated	December 4, 2013
Last verified	November 2013

Tracking Information[ + expand ][ + ]

First Received Date	November 8, 2013
Last Updated Date	December 4, 2013
Start Date	March 2013
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	3rd trimester glycated hemoglobin [Time Frame: 3rd trimester of pregnancy] [Designated as safety issue: No]mean difference of 3rd trimester glycated hemoglobin total maternal weight gain [Time Frame: during pregnancy] [Designated as safety issue: No]mean difference of total maternal weight gain (as defined by the authors) severe maternal hypoglycemia [Time Frame: from enrollment to delivery] [Designated as safety issue: No]relative risk of severe maternal hypoglycemia (as defined by the authors) preeclampsia [Time Frame: during pregnancy or puerperium] [Designated as safety issue: No]relative risk of preeclampsia (as defined by the authors) cesarean section [Time Frame: at the end of pregnancy] [Designated as safety issue: No]relative risk of cesarean section (as defined by the authors) gestational age at birth [Time Frame: at birth] [Designated as safety issue: No]mean difference of gestational age at birth (as defined by the authors) preterm birth [Time Frame: at birth] [Designated as safety issue: No]relative risk of preterm birth (as defined by the authors) birthweight [Time Frame: at birth] [Designated as safety issue: No]mean difference of birthweight (as defined by the authors) macrosomia [Time Frame: at birth] [Designated as safety issue: No]relative risk of macrosomia (defined as birthweight >=4000 g) large-for-gestational age newborn [Time Frame: at birth] [Designated as safety issue: No]relative risk of large-for-gestational age newborn (as defined by the authors) small-for-gestational age newborn [Time Frame: at birth] [Designated as safety issue: No]relative risk of small-for-gestational age newborn (as defined by the authors) neonatal hypoglycemia [Time Frame: in the neonatal period] [Designated as safety issue: No]relative risk of neonatal hypoglycemia (as provided by the authors) perinatal mortality [Time Frame: in the perinatal period] [Designated as safety issue: No]relative risk of perinatal mortality (as defined by the authors) insulin treatment [Time Frame: from enrollment to delivery] [Designated as safety issue: No]relative risk of insulin treatment (for trials comparing metformin vs glyburide)
Current Secondary Outcome Measures	fasting blood glucose [Time Frame: in the period from enrollment to delivery] [Designated as safety issue: No]mean difference of fasting blood glucose (as defined by the authors) postprandial blood glucose [Time Frame: in the period from enrollment to delivery] [Designated as safety issue: No]mean difference of postprandial blood glucose (as defined by the authors) maternal weight gain since enrollment [Time Frame: in the period from enrollment to delivery] [Designated as safety issue: No]mean difference of maternal weight gain since enrollment (as defined by the authors) pregnancy-induced hypertension [Time Frame: during pregnancy] [Designated as safety issue: No]relative risk of pregnancy-induced hypertension (as defined by the authors) induction of labour [Time Frame: at the end of pregnancy] [Designated as safety issue: No]relative risk of induction of labour (as described by the authors) cord C peptide [Time Frame: at birth] [Designated as safety issue: No]mean difference of cord C peptide (as defined by the authors) cord insulin [Time Frame: at birth] [Designated as safety issue: No]mean difference of cord insulin (as defined by the authors) abnormal 1 min Apgar [Time Frame: at birth] [Designated as safety issue: No]relative risk of abnormal 1 min Apgar (defined as lower than 7) abnormal 5 min Apgar [Time Frame: at birth] [Designated as safety issue: No]relative risk of abnormal 5 min Apgar (defined as lower than 7) obstetric trauma [Time Frame: at birth] [Designated as safety issue: No]relative risk of obstetric trauma (as defined by the authors) severe neonatal hypoglycemia [Time Frame: in the neonatal period] [Designated as safety issue: No]relative risk of severe neonatal hypoglycemia (as defined by the authors) neonatal jaundice [Time Frame: in the neonatal period] [Designated as safety issue: No]relative risk of neonatal jaundice (as defined by the authors) significant respiratory distress [Time Frame: in the neonatal period] [Designated as safety issue: No]relative risk of significant respiratory distress (described as respiratory distress syndrome or requiring respiratory support) stillbirth [Time Frame: in the antenatal period] [Designated as safety issue: No]relative risk of stillbirth (as defined by the authors) neonatal mortality [Time Frame: in the neonatal period] [Designated as safety issue: No]relative risk of neonatal mortality (as defined by the authors) Neonatal Intensive Care Unit (NICU) admittance [Time Frame: in the neonatal period] [Designated as safety issue: No]relative risk of NICU admittance (as defined by the authors)

Descriptive Information[ + expand ][ + ]

Brief Title	Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. Systematic Review
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.
Brief Summary	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)
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.
Study Type	Observational
Study Phase	N/A
Study Design	Time Perspective: Retrospective
Condition	Gestational Diabetes Mellitus
Intervention	Drug: Glyburide vs Insulin trials Affecting groups 1 and 2 Drug: Metformin vs Insulin trials Affecting groups 3 and 4 Drug: Metformin vs Glyburide trials Affecting groups 5 and 6
Study Arm (s)	Glyburide (Glyburide vs Insulin) Glyburide vs Insulin trials Insulin (Glyburide vs Insulin) Glyburide vs Insulin trials Metformin (Metformin vs Insulin) Metformin vs Insulin trials Insulin (Metformin vs Insulin) Metformin vs Insulin trials Metformin (Metformin vs Glyburide) Metformin vs Glyburide trials Glyburide (Metformin vs Glyburide) Metformin vs Glyburide trials

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	Not Provided
Estimated Completion Date	December 2013
Estimated Primary Completion Date	November 2013
Eligibility Criteria	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
Gender	Female
Ages	N/A
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Spain

Administrative Information[ + expand ][ + ]

NCT Number	NCT01998113
Other Study ID Numbers	IIBSP-ADO-2013-153
Has Data Monitoring Committee	No
Information Provided By	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	November 2013

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