MedTrace Logo

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

NCT01998113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2509

Last updated 2015-03-24

No results posted yet for this study

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)

Conditions

  • Gestational Diabetes Mellitus

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01998113 on ClinicalTrials.gov