Evidence map›Paper›PMID 25275271›Full record

Trial reportPancreas2014

LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial.

William M Steinberg, Michael A Nauck, Bernard Zinman, Gilbert H Daniels, Richard M Bergenstal, Johannes F E Mann, Lasse Steen Ravn, Alan C Moses, Mette Stockner, Florian M M Baeres and 3 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pancreas, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01179048. Cited by 35 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 4 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT01179048 phase3completed

A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

Ran2010Enrolled9,341Registered outcomes6Posted comparisons20ConditionsDiabetes, Diabetes Mellitus, Type 2Armsliraglutide, Placebo
PMID 28476871PMID 29947247PMID 24176437PMID 30851070PMID 29760228PMID 30508430PMID 30566004PMID 30566006PMID 30260088PMID 29903847PMID 25656058PMID 26855018other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 4 syntheses or guidelines pooled it, 76 citations in OpenAlex.

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  9. Pancreatic Hyperenzymemia in Inflammatory Bowel Disease: Clinical Characterization and Outcomes from the European PANDORA Registry.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
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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

13 authors at 7 institutions in 4 countries.

William M SteinbergFrom the *Department of Medicine, George Washington University Medical Center, Rockville, MD; †Department of Internal Medicine/Diabetology, Diabeteszentrum Bad Lauterberg, Bad Lauterberg im Harz, Germany; ‡Department of Medicine, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada; §Thyroid Unit and Department of Medicine, Massachusetts General Hospital Harvard Medical School, Boston, MA; ║Park Nicollet Institute for Research and Education, International Diabetes Center, Minneapolis, MN; ¶Department of Medicine, Friedrich Alexander University of Erlangen, Erlangen, Germany; #Novo Nordisk, A/S, Bagsvaerd, Denmark; **Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern, Dallas, TX; and ††Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.
Michael A Nauck
Bernard Zinman
Gilbert H Daniels
Richard M Bergenstal
Johannes F E Mann
Lasse Steen Ravn
Alan C Moses
Mette Stockner
Florian M M Baeres
Steven P Marso
John B Buse
LEADER Trial investigators
Novo Nordisk (Denmark) · DKDiabeteszentrum Bad Lauterberg · DEThe University of Texas Southwestern Medical Center · USFriedrich-Alexander-Universität Erlangen-Nürnberg · DELunenfeld-Tanenbaum Research Institute · CAMassachusetts General Hospital · USPark Nicollet Health Services · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis report from the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial describes baseline lipase and amylase activity in type 2 diabetic subjects without acute pancreatitis symptoms before randomization to the glucagonlike peptide analog liraglutide or placebo.

methodsThe LEADER is an international randomized placebo-controlled trial evaluating the cardiovascular safety of liraglutide in 9340 type 2 diabetic patients at high cardiovascular risk. Fasting lipase and amylase activity was assessed at baseline, before receiving liraglutide or placebo, using a commercial assay (Roche) with upper limit of normal values of 63 U/L for lipase and 100 U/L for amylase.

resultsEither or both enzymes were above the upper limit of normal in 22.7% of subjects; 16.6% (n = 1540) had an elevated lipase level (including 1.2% >3-fold elevated), and 11.8% (n = 1094) had an elevated amylase level (including 0.2% >3-fold elevated). In multivariable regression models, severely reduced kidney function was associated with the largest effect on increasing activity of both. However, even among subjects with normal kidney function, 12.2% and 7.7% had elevated lipase and amylase levels.

conclusionsIn this large study of type 2 diabetic patients, nearly 25% had elevated lipase or amylase levels without symptoms of acute pancreatitis. The clinician must take these data into account when evaluating abdominal symptoms in type 2 diabetic patients.

Indexed as

Acute DiseaseAgedAmylasesBiomarkersDiabetes Mellitus, Type 2Double-Blind MethodFastingFemaleGlucagon-Like Peptide 1HumansHypoglycemic AgentsKidneyLipaseLiraglutideMaleMiddle AgedAmylasesBiomarkersGlucagon-Like Peptide 1Hypoglycemic AgentsLipaseLiraglutide

Identifiers

PMID25275271
PMCPMC4206347
OpenAlexW2139076767

What OpenQuestion holds

Texttitle and abstract
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.