Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01998113
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2013-11-08
Brief Title:
Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus Systematic Review
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Since the publication in the New England Journal of Medicine NEJM in 2000 of the Langers 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None