Evidence map›Paper›PMID 40390307›Full record

Trial reportBritish journal of clinical pharmacology2025

Pharmacokinetics and pharmacodynamics of empagliflozin in paediatric patients aged 10-17 years with type 2 diabetes mellitus.

Juliane Rascher, Shen Cheng, Curtis Johnston, Sebastian Härtter, Wojtyniak Jan-Georg, Jan Marquard, Igor Tartakovsky, Lori M B Laffel

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
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

8 authors.

Juliane RascherBoehringer Ingelheim Pharma, Biberach, Germany.ORCID https://orcid.org/0009-0009-4131-7104
Shen ChengMetrum Research Group, Tariffville, CT, USA.ORCID https://orcid.org/0000-0002-7493-4784
Curtis JohnstonMetrum Research Group, Tariffville, CT, USA.
Sebastian HärtterBoehringer Ingelheim Pharma, Ingelheim, Germany.
Wojtyniak Jan-GeorgBoehringer Ingelheim Pharma, Ingelheim, Germany.
Jan MarquardBoehringer Ingelheim Pharma, Ridgefield, CT, USA.
Igor TartakovskyBoehringer Ingelheim International, Ingelheim, Germany.
Lori M B LaffelJoslin Diabetes Center, Harvard Medical School, Boston, MA, USA.

Funding

Boehringer Ingelheim & Eli Lilly and Company Alliance
6 · The paper itself

Abstract

aimsTo characterize the pharmacokinetics (PK) and PK/pharmacodynamics (PD) regarding glycosylated haemoglobin (HbA

methodsPopulation PK and PK/PD models previously developed for empagliflozin in adults and adolescents were re-estimated in a Bayesian framework. The PK model included 223 observations from 74 patients receiving empagliflozin 10 mg and 25 mg and the PK/PD model used 394 observations from 103 patients receiving empagliflozin (n = 52) or placebo (n = 51).

resultsEmpagliflozin PK was well described by a 2-compartment model with sequential zero-order and first-order absorption, with tested covariate effects of sex, age, race and estimated glomerular filtration rate on apparent clearance, and fixed allometric exponents on apparent clearance, apparent central volume of distribution, apparent intercompartmental clearance and apparent peripheral volume of distribution. Simulations of area under the curve at steady state (AUC

conclusionA Bayesian estimation framework enabled the characterization of empagliflozin PK and PK/PD with a limited number of samples in paediatric patients aged 10-17 years. Overall, the results confirm 10 and 25 mg as the appropriate empagliflozin doses in paediatric patients aged 10-17 years with type 2 diabetes mellitus.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesModels, BiologicalSodium-Glucose Transporter 2 InhibitorsAdolescentAdultAge FactorsArea Under CurveBayes TheoremChildDose-Response Relationship, DrugDouble-Blind MethodFemaleGlycated HemoglobinHumansBenzhydryl CompoundsempagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanSodium-Glucose Transporter 2 InhibitorsBayesian estimationchildrenempagliflozinpharmacokineticspharmacokinetics/pharmacodynamicssodium/glucose cotransporter 2 inhibitortype 2 diabetes mellitus

Identifiers

PMID40390307
PMCPMC12304805

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.