Evidence map›Paper›PMID 29971527›Full record

Trial reportDiabetologia2018

Effects of dapagliflozin and n-3 carboxylic acids on non-alcoholic fatty liver disease in people with type 2 diabetes: a double-blind randomised placebo-controlled study.

Jan W Eriksson, Per Lundkvist, Per-Anders Jansson, Lars Johansson, Mats Kvarnström, Linda Moris, Tasso Miliotis, Gun-Britt Forsberg, Ulf Risérus, Lars Lind and 1 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02279407. Cited by 191 papers, 27 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
191citing papers in PubMed, 27 pooled it
25.6field-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.

NCT02279407 phase2completed

A Double-blind Randomized Placebo-controlled, Parallel-group 12 Week Study to Investigate the Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Type 2 Diabetic Patients; EFFECT II

Ran2015Enrolled223Registered outcomes2Posted comparisons3ConditionsT2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)Armsdapagliflozin, Omega-3 carboxylic acids, Placebo, Placebo
Open the trial in the graph
NCT05605158 phase3unknown statusnot on this mapstarted 2022, after this paper: background citation

Comparative Clinical Study to Evaluate the Possible Beneficial Effect of Empagliflozin Versus Pioglitazone on Non-diabetic Patients With Non-Alcoholic Steatohepatitis

TypeinterventionalSponsorTanta UniversityRan2022 to 2024Enrolled56ConditionsNon Alcoholic SteatohepatitisArmsPioglitazone 30mg, Empagliflozin 10 MG
3 · Its place in the literature

Who cites it

191 citing papers in PubMed, 27 syntheses or guidelines pooled it, 379 citations in OpenAlex.

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

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

11 authors at 6 institutions in 1 country.

Jan W ErikssonDepartment of Medical Sciences, Uppsala University, Uppsala University Hospital, 751 85, Uppsala, Sweden. jan.eriksson@medsci.uu.se.
Per LundkvistDepartment of Medical Sciences, Uppsala University, Uppsala University Hospital, 751 85, Uppsala, Sweden.
Per-Anders JanssonDepartment of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.
Lars JohanssonAntaros Medical AB, Gothenburg, Sweden.
Mats KvarnströmAstraZeneca Gothenburg, Gothenburg, Sweden.
Linda MorisKarolinska Trial Alliance, Karolinska University Hospital, Stockholm, Sweden.
Tasso MiliotisAstraZeneca Gothenburg, Gothenburg, Sweden.
Gun-Britt ForsbergAstraZeneca Gothenburg, Gothenburg, Sweden.
Ulf RisérusDepartment of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
Lars LindDepartment of Medical Sciences, Uppsala University, Uppsala University Hospital, 751 85, Uppsala, Sweden.
Jan OscarssonAstraZeneca Gothenburg, Gothenburg, Sweden.
AstraZeneca (Sweden) · SEUppsala University Hospital · SEAntaros Medical (Sweden) · SEKarolinska University Hospital · SEUniversity of Gothenburg · SEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThe EFFECT-II study aimed to investigate the effects of dapagliflozin and omega-3 (n-3) carboxylic acids (OM-3CA), individually or combined, on liver fat content in individuals with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD).

methodsThis randomised placebo-controlled double-blind parallel-group study was performed at five clinical research centres at university hospitals in Sweden. 84 participants with type 2 diabetes and NAFLD were randomly assigned 1:1:1:1 to four treatments by a centralised randomisation system, and all participants as well as investigators and staff involved in the study conduct and analyses were blinded to treatments. Each group received oral doses of one of the following: 10 mg dapagliflozin (n = 21), 4 g OM-3CA (n = 20), a combination of both (n = 22) or placebo (n = 21). The primary endpoint was liver fat content assessed by MRI (proton density fat fraction [PDFF]) and, in addition, total liver volume and markers of glucose and lipid metabolism as well as of hepatocyte injury and oxidative stress were assessed at baseline and after 12 weeks of treatment (completion of the trial).

resultsParticipants had a mean age of 65.5 years (SD 5.9), BMI 31.2 kg/m CONCLUSIONS/

interpretationCombined treatment with dapagliflozin and OM-3CA significantly reduced liver fat content. Dapagliflozin monotherapy reduced all measured hepatocyte injury biomarkers and FGF21, suggesting a disease-modifying effect in NAFLD.

trial registrationClinicalTrials.gov NCT02279407

fundingThe study was funded by AstraZeneca.

Indexed as

AgedBenzhydryl CompoundsBiomarkersCarboxylic AcidsDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFatty AcidsFemaleGlucoseGlucosidesHepatocytesHumansInflammationLipid MetabolismLiver Function TestsBenzhydryl CompoundsBiomarkersCarboxylic AcidsdapagliflozinFatty AcidsGlucoseGlucosidesDapagliflozinDocosahexaenoic acidEicosapentaenoic acidLiver steatosisNon-alcoholic fatty liver diseaseOmega-3 fatty acidsProton density fat fractionType 2 diabetes

Identifiers

PMID29971527
PMCPMC6096619
OpenAlexW2810729752

What OpenQuestion holds

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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 OpenQuestion graph.