Evidence map›Paper›PMID 11036118›Full record

Trial reportThe New England journal of medicine2000

A comparison of glyburide and insulin in women with gestational diabetes mellitus.

O Langer, D L Conway, M D Berkus, E M Xenakis, O Gonzales

2 registry-linked trialsAbstract readClinical TrialComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 163 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
163citing papers in PubMed, 19 pooled it
29.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01998113 completedstarted 2013, after this paper: background citation

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.

Ran2013Enrolled2,509Registered outcomes30Posted comparisons0ConditionsGestational Diabetes MellitusArmsGlyburide vs Insulin trials, Metformin vs Glyburide trials, Metformin vs Insulin trials
PMID 18463376PMID 23724063PMID 19104375PMID 20739011PMID 22505499other papers from this trial
Open the trial in the graph
NCT03380546 phase3terminatednot on this mapstarted 2018, after this paper: background citation

Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. ACARB-GDM Study.

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2018 to 2024Enrolled341ConditionsGestational Diabetes Mellitus in PregnancyArmsAcarbose, Prandial insulin
3 · Its place in the literature

Who cites it

163 citing papers in PubMed, 19 syntheses or guidelines pooled it, 937 citations in OpenAlex.

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  6. Insulin for the treatment of women with gestational diabetes.The Cochrane database of systematic reviews · 2017
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  19. Treatments for gestational diabetes.The Cochrane database of systematic reviews · 2009
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103 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

O LangerDepartment of Obstetrics and Gynecology, St. Luke's-Roosevelt Hospital Center, New York 10019, USA. olanger@slrhc.org
D L Conway
M D Berkus
E M Xenakis
O Gonzales
The University of Texas Health Science Center at San Antonio · USSt. Luke's-Roosevelt Hospital Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWomen with gestational diabetes mellitus are rarely treated with a sulfonylurea drug, because of concern about teratogenicity and neonatal hypoglycemia. There is little information about the efficacy of these drugs in this group of women.

methodsWe studied 404 women with singleton pregnancies and gestational diabetes that required treatment. The women were randomly assigned between 11 and 33 weeks of gestation to receive glyburide or insulin according to an intensified treatment protocol. The primary end point was achievement of the desired level of glycemic control. Secondary end points included maternal and neonatal complications.

resultsThe mean (+/-SD) pretreatment blood glucose concentration as measured at home for one week was 114+/-19 mg per deciliter (6.4+/-1.1 mmol per liter) in the glyburide group and 116+/-22 mg per deciliter (6.5+/-1.2 mmol per liter) in the insulin group (P=0.33). The mean concentrations during treatment were 105+/-16 mg per deciliter (5.9+/-0.9 mmol per liter) in the glyburide group and 105+/-18 mg per deciliter (5.9+/-1.0 mmol per liter) in the insulin group (P=0.99). Eight women in the glyburide group (4 percent) required insulin therapy. There were no significant differences between the glyburide and insulin groups in the percentage of infants who were large for gestational age (12 percent and 13 percent, respectively); who had macrosomia, defined as a birth weight of 4000 g or more (7 percent and 4 percent); who had lung complications (8 percent and 6 percent); who had hypoglycemia (9 percent and 6 percent); who were admitted to a neonatal intensive care unit (6 percent and 7 percent); or who had fetal anomalies (2 percent and 2 percent). The cord-serum insulin concentrations were similar in the two groups, and glyburide was not detected in the cord serum of any infant in the glyburide group.

conclusionsIn women with gestational diabetes, glyburide is a clinically effective alternative to insulin therapy.

Indexed as

AdolescentAdultBlood GlucoseCongenital AbnormalitiesDiabetes, GestationalFemaleFetal BloodFetal MacrosomiaGlyburideHumansHypoglycemiaHypoglycemic AgentsInfant, NewbornInsulinPregnancyPregnancy OutcomeBlood GlucoseGlyburideHypoglycemic AgentsInsulin

Identifiers

PMID11036118
OpenAlexW2326851691

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.