Evidence map›Paper›PMID 26080652›Full record

Trial reportDiabetes, obesity & metabolism2015

Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4-week, randomized, placebo-controlled trial (EASE-1).

T R Pieber, S Famulla, J Eilbracht, J Cescutti, N Soleymanlou, O E Johansen, H J Woerle, U C Broedl, S Kaspers

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 7 pooled it
16.8field-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.

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

59 citing papers in PubMed, 7 syntheses or guidelines pooled it, 164 citations in OpenAlex.

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  16. Trajectory of Kidney Function in T1D over Time: A Scoping Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
    Review
  17. Latent autoimmune diabetes in youth.Frontiers in immunology · 2025
    Review
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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

9 authors at 6 institutions in 5 countries.

T R PieberDivision of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
S FamullaProfil, Neuss, Germany.
J EilbrachtBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
J CescuttiBoehringer Ingelheim France, Reims, France.
N SoleymanlouBoehringer Ingelheim Canada Ltd./Ltee, Burlington, Canada.
O E JohansenBoehringer Ingelheim Norway K.S, Asker, Norway.
H J WoerleBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
U C BroedlBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
S KaspersBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (Canada) · CABoehringer Ingelheim (France) · FRBoehringer Ingelheim (Norway) · NOMedical University of Graz · ATProfil Institute for Metabolic Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the pharmacodynamics, efficacy and safety of empagliflozin as adjunct to insulin in patients with type 1 diabetes.

methodsA total of 75 patients with glycated haemoglobin (HbA1c) concentrations of ≥7.5 to ≤10.5% (≥58 to ≤91 mmol/mol) were randomized to receive once-daily empagliflozin 2.5 mg, empagliflozin 10 mg, empagliflozin 25 mg, or placebo as adjunct to insulin for 28 days. Insulin dose was to be kept as stable as possible for 7 days then adjusted, at the investigator's discretion, to achieve optimum glycaemic control. The primary exploratory endpoint was change from baseline in 24-h urinary glucose excretion (UGE) on day 7.

resultsEmpagliflozin significantly increased 24-h UGE versus placebo on days 7 and 28. On day 28, adjusted mean differences with empagliflozin versus placebo in changes from baseline in: HbA1c were -0.35 to -0.49% (-3.8 to -5.4 mmol/mol; all p < 0.05 vs. placebo); total daily insulin dose -0.07 to -0.09 U/kg (all p<0.05 vs placebo); and weight were -1.5 to -1.9 kg (all p < 0.001 vs. placebo). In the placebo, empagliflozin 2.5, 10 and 25 mg groups, respectively, adverse events were reported in 94.7, 89.5, 78.9 and 100.0% of patients, and the rate of symptomatic hypoglycaemic episodes with glucose ≤3.0 mmol/l not requiring assistance was 1.0, 0.4, 0.5 and 0.8 episodes per 30 days.

conclusionsIn patients with type 1 diabetes, empagliflozin for 28 days as adjunct to insulin increased UGE, improved HbA1c and reduced weight with lower insulin doses compared with placebo and without increasing hypoglycaemia.

Indexed as

AdultAustriaBenzhydryl CompoundsDiabetes Mellitus, Type 1Dose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleGermanyGlucosidesGlycated HemoglobinGlycosuriaHumansHypoglycemiaHypoglycemic AgentsInsulinBenzhydryl CompoundsempagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinpharmacodynamicspharmacologySGLT2 inhibitortype 1 diabetes

Identifiers

PMID26080652
PMCPMC4745028
OpenAlexW2099670937

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 OpenQuestion graph.