Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01998113
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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)


Condition or disease Intervention/treatment
Gestational Diabetes Mellitus Drug: Glyburide vs Insulin trials Drug: Metformin vs Insulin trials Drug: Metformin vs Glyburide trials

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 2509 participants
Time Perspective: Retrospective
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 Start Date : March 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Glyburide (Glyburide vs Insulin)
Glyburide vs Insulin trials
Drug: Glyburide vs Insulin trials
Affecting groups 1 and 2

Insulin (Glyburide vs Insulin)
Glyburide vs Insulin trials
Drug: Glyburide vs Insulin trials
Affecting groups 1 and 2

Metformin (Metformin vs Insulin)
Metformin vs Insulin trials
Drug: Metformin vs Insulin trials
Affecting groups 3 and 4

Insulin (Metformin vs Insulin)
Metformin vs Insulin trials
Drug: Metformin vs Insulin trials
Affecting groups 3 and 4

Metformin (Metformin vs Glyburide)
Metformin vs Glyburide trials
Drug: Metformin vs Glyburide trials
Affecting groups 5 and 6

Glyburide (Metformin vs Glyburide)
Metformin vs Glyburide trials
Drug: Metformin vs Glyburide trials
Affecting groups 5 and 6




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pregnant women with gestational diabetes mellitus requiring drug treatment
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998113


Locations
Layout table for location information
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01998113    
Other Study ID Numbers: IIBSP-ADO-2013-153
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: November 2013
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
gestational diabetes mellitus
glyburide
metformin
oral agents
insulin
outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin
Insulin, Globin Zinc
Metformin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs