Evidence map›Paper›PMID 39546502›Full record

Trial reportPloS one2024

Glycemia reduction in type 2 diabetes-Hypoglycemia outcomes: A randomized clinical trial.

Elizabeth R Seaquist, Lawrence S Phillips, Alokananda Ghosh, Chelsea Baker, Richard M Bergenstal, Jill P Crandall, Robin S Goland, Michaela R Gramzinski, Sophia H Hox, Daniel S Hsia and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01794143. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT01794143 phase3completed

Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study

Ran2013Enrolled7,850Registered outcomes4Posted comparisons0ConditionsComparative Effectiveness of Glycemia-lowering Medications, Type 2 DiabetesArmsDPP-4 inhibitor (sitagliptin), GLP-1 receptor agonist (liraglutide), Insulin (glargine), Sulfonylurea (glimepiride)
Open the trial in the graph
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Elizabeth R SeaquistDepartment of Medicine, Division of Diabetes and Endocrinology, University of Minnesota Medical School, Minneapolis, MN, United States of America.ORCID https://orcid.org/0000-0002-1945-1034
Lawrence S PhillipsDepartment of Medicine, Atlanta VA Medical Center, Decatur, GA and Division of Endocrinology and Metabolism, Emory University School of Medicine, Atlanta, GA, United States of America.
Alokananda GhoshDepartment of Biostatistics and Bioinformatics, Milken Institute of Public Health, The Biostatistics Center, The George Washington University, Rockville, MD, United States of America.ORCID https://orcid.org/0000-0001-5311-056X
Chelsea BakerDepartment of Medicine, Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, United States of America.ORCID https://orcid.org/0000-0002-9807-7115
Richard M BergenstalHealth Partners Institute, International Diabetes Center, Minneapolis, MN, United States of America.ORCID https://orcid.org/0000-0002-9050-5584
Jill P CrandallDivision of Endocrinology and Fleischer Institute for Diabetes & Metabolism, Albert Einstein College of Medicine, Bronx, NY, United States of America.
Robin S GolandDepartments of Medicine and Pediatrics, Naomi Berrie Diabetes Center, Columbia University, New York, NY, United States of America.
Michaela R GramzinskiDepartment of Biostatistics and Bioinformatics, Milken Institute of Public Health, The Biostatistics Center, The George Washington University, Rockville, MD, United States of America.ORCID https://orcid.org/0009-0001-1662-7196
Sophia H HoxDepartment of Veterans Affairs Pacific Islands Health Care System, Honolulu, HI, United States of America.
Daniel S HsiaClinical Trials Unit, Pennington Biomedical Research Center, Baton Rouge, LA, United States of America.ORCID https://orcid.org/0000-0003-2832-3429
Mary L JohnsonHealth Partners Institute, International Diabetes Center, Minneapolis, MN, United States of America.
John M LachinDepartment of Biostatistics and Bioinformatics, Milken Institute of Public Health, The Biostatistics Center, The George Washington University, Rockville, MD, United States of America.
Philip RaskinUniversity of Texas-Southwestern Medical Center, Dallas, TX, United States of America.
Willy M ValenciaGeriatric Research Education and Clinical Center, Bruce W. Carter Veterans Affairs Center, Miami, FL, United States of America.
Andrea H WaltjeUniversity of Michigan, Ann Arbor, MI, United States of America.
Naji YounesDepartment of Biostatistics and Bioinformatics, Milken Institute of Public Health, The Biostatistics Center, The George Washington University, Rockville, MD, United States of America.
GRADE Research Group

Funding

Glycemia Reduction Approaches in Diabetes: A comparative effectiveness studyU01DK098246 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI KRAUSE-STEINRAUF, HEIDI, LACHIN, JOHN M · 2012 to 2022
$238.9M
Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Peter Todd Katzmarzyk · 2012 to 2026
$69.1M
NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · PI Karin E Bornfeldt · 1986 to 2026
$41.4M
The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI MEINZEN-DERR, JAREEN, STRAWN, JEFFREY ROBERT · 2015 to 2024
$37.5M
NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR001108NCATS NIH HHS UL1 TR001409NCATS NIH HHS UL1 TR001425NCATS NIH HHS UL1 TR001449NCATS NIH HHS UL1 TR002243NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1 TR002378NCATS NIH HHS UL1 TR002489NCATS NIH HHS UL1 TR002529NCATS NIH HHS UL1 TR002535NCATS NIH HHS UL1 TR002537NCATS NIH HHS UL1 TR002548NIDDK NIH HHS P30 DK017047NIDDK NIH HHS P30 DK020541NIDDK NIH HHS P30 DK020572NIDDK NIH HHS P30 DK072476NIDDK NIH HHS P30 DK079626NIDDK NIH HHS P30 DK092926NIDDK NIH HHS P30 DK111022NIDDK NIH HHS U01 DK098246NIDDK NIH HHS U34 DK088043NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

objectiveHypoglycemia is a major concern in type 2 diabetes (T2DM), but little is known about its likelihood compared across common therapies. We compared the likelihood of hypoglycemia among metformin-treated patients with T2DM randomized to the addition of one of 4 common therapies. RESEARCH DESIGN &

methodsRandomized, controlled trial of 5,047 participants with T2DM of <10 years' duration, hemoglobin A1c (HbA1c) 6.8-8.5% (50.8-69.4 mmol/mol). Randomization to addition of glargine U100, glimepiride, liraglutide, or sitagliptin over 5.0 ± 1.3 (mean ± SD) years. HbA1c was measured quarterly; if a level >7.5% (>58.5 mmol/mol) was confirmed, rescue glargine and/or aspart insulin was added. We conducted a per-protocol analysis of 4,830, who attended at least one post-baseline visit and took at least one dose of assigned study medication. We assessed severe hypoglycemia events reported throughout the entire study. At quarterly visits, all participants were asked about hypoglycemic symptoms within the last 30 days, and those in the glargine and glimepiride groups were asked for any measured glucose <70 mg/dL (3.9 mmol/L) within this time period.

resultsWhile participants were taking their assigned medications, severe hypoglycemia occurred in 10 (0.8%), 16 (1.3%), 6 (0.5%), and 4 (0.3%), (p<0.05) and hypoglycemic symptoms in 659 (54.2%), 833 (68.3%), 375 (32.4%), and 361 (29.1%) of participants following randomization to glargine, glimepiride, liraglutide, and sitagliptin, respectively (p<0.001).

conclusionsIn metformin-treated patients with T2DM who add a second medication, hypoglycemia is most likely with addition of glimepiride, less with glargine, and least likely with liraglutide and sitagliptin.

trial registrationClinicalTrials.gov Identifier: NCT01794143.

Indexed as

Blood GlucoseDiabetes Mellitus, Type 2Glycemic ControlHypoglycemiaHypoglycemic AgentsAgedFemaleGlycated HemoglobinHumansInsulin GlargineLiraglutideMaleMetforminMiddle AgedSitagliptin PhosphateSulfonylurea CompoundsBlood GlucoseglimepirideGlycated HemoglobinHypoglycemic AgentsInsulin GlargineLiraglutideMetforminSitagliptin PhosphateSulfonylurea Compounds

Identifiers

PMID39546502
PMCPMC11567630

What Socratic holds

Texttitle and abstract
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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 Socratic graph.