Evidence map›Paper›PMID 29655290›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2018

Pharmacokinetic and pharmacodynamic profile of the sodium-glucose co-transporter-2 inhibitor empagliflozin in young people with Type 2 diabetes: a randomized trial.

L M B Laffel, W V Tamborlane, A Yver, G Simons, J Wu, V Nock, D Hobson, K S Hughan, S Kaspers, J Marquard

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02121483. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
–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.

NCT02121483 phase1completed

An Open-label, Randomised, Multicentre, Single-dose, Parallel Group Trial to Evaluate Pharmacokinetics and Pharmacodynamics of Empagliflozin in Children and Adolescents From 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus

Ran2014Enrolled27Registered outcomes8Posted comparisons3ConditionsDiabetes Mellitus, Type 2Armsempagliflozin high dose, empagliflozin low dose, empagliflozin medium dose
Open the trial in the graph
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  10. Article
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  17. Research progress on the effects of sodium-glucose linked transporter 2 inhibitors on multiple metabolic disorders in metabolic syndrome.Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2024
    Review
  18. Article
  19. Article
  20. Complications and Treatment of Early-Onset Type 2 Diabetes.International journal of endocrinology and metabolism · 2023
    Review
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

10 authors.

L M B LaffelHarvard Medical School, Joslin Diabetes Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-9675-3001
W V TamborlaneYale School of Medicine, New Haven, CT, USA.
A YverBoehringer Ingelheim, Reims, France.
G SimonsBoehringer Ingelheim International GmbH, Biberach an der Riss, Germany.
J WuBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
V NockBoehringer Ingelheim International GmbH, Biberach an der Riss, Germany.
D HobsonBoehringer Ingelheim International GmbH, Biberach an der Riss, Germany.
K S HughanDivision of Pediatric Endocrinology, Metabolism and Diabetes Mellitus, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
S KaspersBoehringer Ingelheim International GmbH, Ingelheim, Germany.
J MarquardBoehringer Ingelheim International GmbH, Ingelheim, Germany.

Funding

PILOT STUDY--SECRETORY TARGETING IN PANCREATIC B CELLSP30DK036836 · JOSLIN DIABETES CENTER · 1986 to 2025
$12.1M
RESEARCH TRAINING IN PEDIATRIC ENDOCRINOLOGY &DIABETEST32DK007729 · CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS · 1995 to 2005
$822k
NIDDK NIH HHS P30 DK036836NIDDK NIH HHS T32 DK007729
6 · The paper itself

Abstract

aimsTo assess the pharmacokinetic and pharmacodynamic profile of a single dose of empagliflozin in young people with Type 2 diabetes to identify the appropriate doses for further paediatric development.

methodsWe conducted a single-dose, open-label, randomized, parallel-group study with empagliflozin 5 mg, 10 mg and 25 mg in young people with Type 2 diabetes aged 10-17 years.

resultsOf 39 participants screened, 27 were randomized and completed the study; their mean (± sd) age was 14.1±2.0 years and body weight was 96.7±23.5 kg. Compared with similar studies in adults with Type 2 diabetes, the maximum observed plasma concentrations were slightly lower with the 10-mg and 25-mg doses, and the area under the plasma concentration-time curve was slightly lower with the 10-mg but slightly higher with the 25-mg dose. The adjusted mean increases in urinary glucose excretion were 53 g/24 h (95% CI 32,74), 73 g/24 h (95% CI 52,94) and 87 g/24 h (95% CI 68,107), and the adjusted mean decreases in fasting plasma glucose were 0.9 mmol/l (95% CI -1.6,-0.1), 0.9 mmol/l (95% CI -1.7,-0.2) and 1.1 mmol/l (95% CI -1.8,-0.5) for the 5- 10- and 25-mg doses, respectively. There were no serious adverse events and one investigator-reported drug-related event (dehydration).

conclusionsAfter a single oral dose of empagliflozin, adults and young people with Type 2 diabetes had similar exposure-response relationships after adjusting for significant covariates. These data support testing 10-mg and/or 25-mg doses of empagliflozin in an upcoming paediatric phase III Type 2 diabetes trial. (ClinicalTrials.gov registration no.: NCT02121483).

Indexed as

Administration, OralAdolescentBenzhydryl CompoundsBlood GlucoseChildDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFemaleGlucosidesHumansHypoglycemic AgentsMaleSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsBlood GlucoseempagliflozinGlucosidesHypoglycemic AgentsSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID29655290
PMCPMC6099360

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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.