Evidence map›Paper›PMID 23906374›Full record

Trial reportDiabetes, obesity & metabolism2013

Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia.

J Rosenstock, L J Seman, A Jelaska, S Hantel, S Pinnetti, T Hach, H J Woerle

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

Trial report in Diabetes, obesity & metabolism, 2013. 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 95 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 19 pooled it
19.4field-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.

NCT05042505 nacompletedstarted 2022, after this paper: background citation

Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation: a Randomized Controlled Trial

Ran2022Enrolled100Registered outcomes5Posted comparisons0ConditionsDiabetes Mellitus, Liver Transplant; ComplicationsArmsDapagliflozin 10mg Tab, Sitagliptin 100mg
PMID 23398530PMID 32865597PMID 26555703PMID 21094444PMID 22025886PMID 22431131PMID 22554256PMID 29895557PMID 32006266other papers from this trial
Open the trial in the graph
NCT02686476 nacompletednot on this mapstarted 2016, after this paper: background citation

Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes: A 12-week Randomized Clinical Study

TypeinterventionalSponsorMedanta, The Medicity, IndiaRan2016 to 2017Enrolled100ConditionsNon Alcoholic Fatty Liver DiseaseArmsEmpagliflozin
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 19 syntheses or guidelines pooled it, 208 citations in OpenAlex.

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35 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

7 authors at 3 institutions in 2 countries.

J RosenstockDallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.
L J Seman
A Jelaska
S Hantel
S Pinnetti
T Hach
H J Woerle
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United States) · USDallas Diabetes Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo evaluate the effects of the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin added to metformin for 12 weeks in patients with type 2 diabetes.

methodsThis dose-ranging, double-blind, placebo-controlled trial randomized 495 participants with type 2 diabetes inadequately controlled on metformin [haemoglobin A1c (HbA1c) >7 to ≤10%] to receive 1, 5, 10, 25, or 50 mg empagliflozin once daily (QD), or placebo, or open-label sitagliptin (100 mg QD), added to metformin for 12 weeks. The primary endpoint was change in HbA1c from baseline to week 12 (empagliflozin groups versus placebo).

resultsReductions in HbA1c of -0.09 to -0.56% were observed with empagliflozin after 12 weeks, versus an increase of 0.15% with placebo (baseline: 7.8-8.1%). Compared with placebo, empagliflozin doses from 5 to 50 mg resulted in reductions in fasting plasma glucose (-2 to -28 mg/dl vs. 5 mg/dl with placebo; p < 0.0001) and body weight (-2.3 to -2.9 kg vs. -1.2 kg; p < 0.01). Frequency of adverse events was generally similar with empagliflozin (29.6-48.6%), placebo (36.6%) and sitagliptin (35.2%). Hypoglycaemia rates were very low and balanced among groups. Most frequent adverse events with empagliflozin were urinary tract infections (4.0% vs. 2.8% with placebo) and pollakiuria (2.5% vs. 1.4% with placebo). Genital infections were reported only with empagliflozin (4.0%).

conclusionsOnce daily empagliflozin as add-on therapy to metformin was well tolerated except for increased genital infections and resulted in reductions in HbA1c, fasting plasma glucose and body weight in patients with type 2 diabetes inadequately controlled on metformin monotherapy.

Indexed as

Analysis of VarianceBenzhydryl CompoundsBlood PressureDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlucosidesGlycated HemoglobinHematocritHumansHyperglycemiaHypoglycemic AgentsMaleMetforminMiddle AgedBenzhydryl CompoundsempagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsMetforminSodium-Glucose Transporter 2 Inhibitorsadd-on therapyblood pressurebody weightempagliflozinHbA1cSGLT2 inhibitortolerability

Identifiers

PMID23906374
OpenAlexW2165956693

What Socratic 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 Socratic graph.