Evidence map›Paper›PMID 27627981›Full record

Trial reportDiabetologia2016

Twelve week liraglutide or sitagliptin does not affect hepatic fat in type 2 diabetes: a randomised placebo-controlled trial.

Mark M Smits, Lennart Tonneijck, Marcel H A Muskiet, Mark H H Kramer, Petra J W Pouwels, Indra C Pieters-van den Bos, Trynke Hoekstra, Michaela Diamant, Daniël H van Raalte, Djuna L Cahen

Registry-linked trialOpen access · hybridFull text readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01744236. Cited by 63 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 13 pooled it
9.7field-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.

NCT01744236 phase4completed

A Phase IV, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Effect of 12-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist (GLP-1RA) Liraglutide or Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Sitagliptin on the Cardiovascular, Renal and Gastrointestinal System in Insulin-naïve Patients With Type 2 Diabetes (T2DM).

Ran2013Enrolled70Registered outcomes6Posted comparisons0ConditionsType 2 DiabetesArmsexenatide, Exenatide placebo, liraglutide, Liraglutide placebo, L-NMMA
Open the trial in the graph
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 13 syntheses or guidelines pooled it, 136 citations in OpenAlex.

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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Mark M SmitsDiabetes Center, Department of Internal Medicine, VU University Medical Center, De Boelelaan 1117 (Room ZH 4A65), 1081 HV, Amsterdam, the Netherlands. mm.smits1@vumc.nl.
Lennart TonneijckDiabetes Center, Department of Internal Medicine, VU University Medical Center, De Boelelaan 1117 (Room ZH 4A65), 1081 HV, Amsterdam, the Netherlands.
Marcel H A MuskietDiabetes Center, Department of Internal Medicine, VU University Medical Center, De Boelelaan 1117 (Room ZH 4A65), 1081 HV, Amsterdam, the Netherlands.
Mark H H KramerDiabetes Center, Department of Internal Medicine, VU University Medical Center, De Boelelaan 1117 (Room ZH 4A65), 1081 HV, Amsterdam, the Netherlands.
Petra J W PouwelsDepartment of Physics and Medical Technology, VU University Medical Center and Neuroscience Campus Amsterdam, Amsterdam, the Netherlands.
Indra C Pieters-van den BosDepartment of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, the Netherlands.
Trynke HoekstraDepartment of Health Sciences and the EMGO Institute for Health and Care Research, VU University Amsterdam, Amsterdam, the Netherlands.
Michaela DiamantDiabetes Center, Department of Internal Medicine, VU University Medical Center, De Boelelaan 1117 (Room ZH 4A65), 1081 HV, Amsterdam, the Netherlands.
Daniël H van RaalteDiabetes Center, Department of Internal Medicine, VU University Medical Center, De Boelelaan 1117 (Room ZH 4A65), 1081 HV, Amsterdam, the Netherlands.
Djuna L CahenDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.
Amsterdam UMC Location VUmc · NLAmsterdam Neuroscience · NLErasmus MC · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisGlucagon-like peptide (GLP)-1-based therapies have been suggested to improve hepatic steatosis. We assessed the effects of the GLP-1 receptor agonist liraglutide and the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin on hepatic steatosis and fibrosis in patients with type 2 diabetes.

methodsIn this 12 week, parallel, randomised, placebo-controlled trial, performed at the VU University Medical Center between July 2013 and August 2015, 52 overweight patients with type 2 diabetes treated with metformin and/or sulphonylurea agent ([mean ± SD] age 62.7 ± 6.9 years, HbA

resultsOne patient dropped out in the sitagliptin group owing to dizziness, but no serious adverse events occurred. At week 12, no between-group differences in hepatic steatosis were found. Liraglutide reduced steatosis by 10% (20.9 ± 3.4% to 18.8 ± 3.3%), sitagliptin reduced steatosis by 12.1% (23.9 ± 3.0% to 21.0 ± 2.7%) and placebo lessened it by 9.5% (18.7 ± 2.7% to 16.9 ± 2.7%). Neither drug affected hepatic fibrosis scores compared with placebo. CONCLUSIONS/

interpretationTwelve-week liraglutide or sitagliptin treatment does not reduce hepatic steatosis or fibrosis in type 2 diabetes.

trial registrationClinicalTrials.gov NCT01744236

fundingFunded by the European Community's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 282521 - the SAFEGUARD project.

Indexed as

AdultAgedDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsFemaleGlucagon-Like Peptide 1Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsHumansHypoglycemic AgentsLiraglutideLiver CirrhosisMagnetic Resonance SpectroscopyMaleMiddle AgedSitagliptin PhosphateDipeptidyl-Peptidase IV InhibitorsGLP1R protein, humanGlucagon-Like Peptide 1Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsHypoglycemic AgentsLiraglutideSitagliptin PhosphateDipeptidyl peptidase-4 inhibitorGlucagon-like peptide-1 receptor agonistNon-alcoholic fatty liver diseaseType 2 diabetes

Identifiers

PMID27627981
PMCPMC6518065
OpenAlexW2520975418

What Socratic holds

Textfull text, public
LicenceCC BY
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 Socratic graph.