Evidence map›Paper›PMID 30287422›Full record

Trial reportDiabetes care2018

Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials.

Julio Rosenstock, Jan Marquard, Lori M Laffel, Dietmar Neubacher, Stefan Kaspers, David Z Cherney, Bernard Zinman, Jay S Skyler, Jyothis George, Nima Soleymanlou and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06894784 (Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes), which is not on this map. Cited by 160 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
160citing papers in PubMed, 13 pooled it
26.0field-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.

NCT06894784 phase3recruitingstarted 2025, after this paper: background citation

Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes (SEMPA)

Ran2025Enrolled36Registered outcomes13Posted comparisons0ConditionsDiabetes Type 1ArmsIntervention Period 1: Semaglutide + Empagliflozin, Intervention Period 2: Semaglutide + Empagliflozin Placebo, Intervention Period 3: Semaglutide Placebo + Empagliflozin, Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

160 citing papers in PubMed, 13 syntheses or guidelines pooled it, 345 citations in OpenAlex.

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100 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 3 countries.

Julio RosenstockDallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com bruce.perkins@sinaihealthsystem.ca.ORCID 0000-0001-8324-3275
Jan MarquardBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Lori M LaffelJoslin Diabetes Center, Harvard Medical School, Boston, MA.ORCID 0000-0002-9675-3001
Dietmar NeubacherBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
Stefan KaspersBoehringer Ingelheim International GmbH, Ingelheim, Germany.
David Z CherneyDivision of Nephrology, Department of Medicine, and Department of Physiology, Toronto General Hospital, University of Toronto, Toronto, Canada.ORCID 0000-0003-4164-0429
Bernard ZinmanLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, and Division of Endocrinology and Metabolism, University of Toronto, Toronto, Canada.ORCID 0000-0002-0041-1876
Jay S SkylerDiabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.ORCID 0000-0003-1136-8110
Jyothis GeorgeBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Nima SoleymanlouBoehringer Ingelheim (Canada) Ltd./Ltée, Burlington, Canada.
Bruce A PerkinsLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, and Division of Endocrinology and Metabolism, University of Toronto, Toronto, Canada juliorosenstock@dallasdiabetes.com bruce.perkins@sinaihealthsystem.ca.ORCID 0000-0002-5885-0046
Boehringer Ingelheim (Germany) · DEMount Sinai Hospital · CABoehringer Ingelheim (Canada) · CADallas Diabetes Research Center · USJoslin Diabetes Center · USUniversity of Miami · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and efficacy of empagliflozin 10- and 25-mg doses plus a unique lower dose (2.5 mg) as adjunct to intensified insulin in patients with type 1 diabetes (T1D). RESEARCH DESIGN AND

methodsThe EASE (Empagliflozin as Adjunctive to inSulin thErapy) program (

resultsThe observed largest mean placebo-subtracted glycated hemoglobin reductions were -0.28% (95% CI -0.42, -0.15) for 2.5 mg, -0.54% (-0.65, -0.42) for 10 mg, and -0.53% (-0.65, -0.42) for 25 mg (all

conclusionsEmpagliflozin improved glycemic control and weight in T1D without increasing hypoglycemia. Ketoacidosis rate was comparable between empagliflozin 2.5 mg and placebo but increased with 10 mg and 25 mg. Ketone monitoring for early ketoacidosis detection and intervention and lower empagliflozin doses may help to reduce this risk.

Indexed as

AdultAgedBenzhydryl CompoundsBlood GlucoseDiabetes Mellitus, Type 1Double-Blind MethodDrug Therapy, CombinationFemaleGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsInsulinMaleMiddle AgedPlacebosBenzhydryl CompoundsBlood GlucoseempagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsInsulinPlacebos

Identifiers

PMID30287422
OpenAlexW2894624538

What OpenQuestion 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 OpenQuestion graph.