Evidence map›Paper›PMID 23356556›Full record

Trial reportDiabetes, obesity & metabolism2013

Safety, tolerability, pharmacokinetics and pharmacodynamics following 4 weeks' treatment with empagliflozin once daily in patients with type 2 diabetes.

T Heise, E Seewaldt-Becker, S Macha, S Hantel, S Pinnetti, L Seman, H J Woerle

Registry-linked trialAbstract 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 trial NCT04298229 (A Randomized, Open-label Study of Dapagliflozin in Patients With or Without Type 2 Diabetes Admitted With Acute Heart Failure), which is not on this map. Cited by 124 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
124citing papers in PubMed, 6 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.

NCT04298229 phase3completedstarted 2020, after this paper: background citation

A Randomized, Open-label Study of Dapagliflozin in Patients With or Without Type 2 Diabetes Admitted With Acute Heart Failure

Ran2020Enrolled240Registered outcomes3Posted comparisons0ConditionsDiabetes Mellitus, Type 2, Heart FailureArmsDapagliflozin 10 mg, Protocolized Diuretic Therapy
PMID 27266853PMID 26299229PMID 26041600PMID 25838436PMID 25287144PMID 24879974PMID 24585267PMID 24379278PMID 24247300PMID 23333145PMID 23141816PMID 21732835other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

124 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  12. Sodium-Glucose Cotransporter-2 Inhibitor Immediately Decreases Serum Uric Acid Levels in Type 2 Diabetic Patients.Medical science monitor : international medical journal of experimental and clinical research · 2020
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64 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.

T HeiseProfil, Hellersbergstrasse 9, Neuss, Germany. tim.heise@profil.com
E Seewaldt-Becker
S Macha
S Hantel
S Pinnetti
L Seman
H J Woerle

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of empagliflozin in patients with type 2 diabetes following oral administration of 10, 25 or 100 mg doses once daily over 28 days.

methodsA total of 78 patients were assigned to empagliflozin 10 mg (n = 16), 25 mg (n = 16) or 100 mg (n = 30) or placebo (n = 16) for 28 days. Assessments included adverse events (AEs) and pharmacokinetic and pharmacodynamic endpoints.

resultsEmpagliflozin exposure increased dose-proportionally over the dose range 10-100 mg and showed linear pharmacokinetics with respect to time. Urinary glucose excretion (UGE) increased from baseline to day 1 by 74, 90 and 81 g with empagliflozin 10, 25 and 100 mg, respectively. The increases in UGE were maintained over 28 days with multiple dosing. Virtually no change in UGE was observed in the placebo group. Significant reductions from baseline in mean daily plasma glucose and fasting plasma glucose were observed with empagliflozin compared with placebo. The incidence of AEs was similar in the empagliflozin and placebo groups (50.0, 56.3 and 66.7% with empagliflozin rising doses and 62.5% with placebo). The most frequently reported AEs were pollakiuria (10.3%), nasopharyngitis (9.0%), constipation (9.0%) and headache (7.7%).

conclusionsOral administration of empagliflozin at doses of 10, 25 or 100 mg once daily over 28 days resulted in significant increases in UGE and reductions in blood glucose compared with placebo, and were well tolerated in patients with type 2 diabetes.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAdministration, OralAdultAgedBenzhydryl CompoundsDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGermanyGlucosidesGlycosuriaHumansHyperglycemiaHypoglycemic AgentsBenzhydryl CompoundsempagliflozinGlucosidesHypoglycemic AgentsMembrane Transport ModulatorsSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID23356556

What OpenQuestion holds

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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 OpenQuestion graph.