Evidence mapPaperPMID 23859488Full record

Trial reportDiabetes, obesity & metabolism2014

Pharmacokinetics, pharmacodynamics and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in subjects with renal impairment.

S Macha, M Mattheus, A Halabi, S Pinnetti, H J Woerle, U C Broedl

2 registry-linked trialsAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2014. 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 56 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 4 pooled it
7.8field-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.

NCT06249932 phase4recruitingstarted 2024, after this paper: background citation

The Safety and Efficacy of Empagliflozin in Patients with End-stage Renal Disease and Heart Failure with Reduced Ejection Fraction - a Randomized Controlled Trial

Ran2024Enrolled95Registered outcomes33Posted comparisons0ConditionsEnd Stage Renal Disease on Dialysis, Heart Failure With Reduced Ejection FractionArmsempagliflozin 25 mg, Placebo
Open the trial in the graph
NCT06249945 phase4recruitingstarted 2024, after this paper: background citation

The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial

Ran2024Enrolled150Registered outcomes27Posted comparisons0ConditionsEnd Stage Renal Disease on Dialysis, Heart Failure With Preserved Ejection FractionArmsempagliflozin 25 mg, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 4 syntheses or guidelines pooled it, 108 citations in OpenAlex.

  1. Pooled it
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  5. Safety and Short-Term Effects of Empagliflozin in Patients with Heart Failure and End-Stage Renal Disease.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
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  15. Acute vascular redox modulation by SGLT2 inhibition in non-diabetic patients.Cardiovascular diabetology. Endocrinology reports · 2026
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  18. Review
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  20. Diabetes and Glucose Management in People on Hemodialysis.Diabetes spectrum : a publication of the American Diabetes Association · 2025
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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

6 authors at 3 institutions in 2 countries.

S MachaBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
M Mattheus
A Halabi
S Pinnetti
H J Woerle
U C Broedl
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United States) · USClinical Research Services · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsEmpagliflozin is a selective sodium glucose cotransporter 2 (SGLT2) inhibitor that inhibits renal glucose reabsorption and is being investigated for the treatment of type 2 diabetes mellitus (T2DM).

methodsIn this open-label study, the effect of renal impairment on the pharmacokinetics, pharmacodynamics and safety of a 50 mg dose of empagliflozin was investigated in 40 subjects, grouped according to estimated glomerular filtration rate (eGFR).

resultsMaximum empagliflozin plasma concentrations were similar in subjects with normal renal function and renal impairment. Area under the empagliflozin concentration-time curve (AUC0 -∞ ) values increased by approximately 18, 20, 66 and 48% in subjects with mild, moderate, severe renal impairment and renal failure/end stage renal disease (ESRD), respectively, in comparison to healthy subjects. This was attributed to decreased renal clearance (CLR ). Urinary glucose excretion (UGE) decreased with increasing renal impairment and correlated with decreased eGFR and CLR . Empagliflozin was well tolerated, with no increase in adverse events associated with renal impairment.

conclusionsRenal insufficiency resulted in decreased CLR of empagliflozin, moderately increased systemic exposure and decreased UGE. A single 50 mg dose of empagliflozin was well tolerated in subjects with normal renal function and any degree of renal impairment. The pharmacokinetic results of this study indicate that no dose adjustment of empagliflozin is required in patients with renal impairment.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAdultAgedArea Under CurveBenzhydryl CompoundsDiabetes Mellitus, Type 2Diabetic NephropathiesDrug Administration ScheduleFastingFemaleGlomerular Filtration RateGlucoseGlucosidesHumansHypoglycemic AgentsMaleBenzhydryl CompoundsempagliflozinGlucoseGlucosidesHypoglycemic AgentsSLC5A2 protein, humanSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 Inhibitorsdiabetesempagliflozinpharmacodynamicspharmacokineticsrenal impairmentSGLT2 inhibitor

Identifiers

PMID23859488
OpenAlexW1994679938

What Socratic holds

Textmetadata
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.