Evidence map›Paper›PMID 26040302›Full record

Trial reportDiabetes, obesity & metabolism2015

Impact of empagliflozin added on to basal insulin in type 2 diabetes inadequately controlled on basal insulin: a 78-week randomized, double-blind, placebo-controlled trial.

J Rosenstock, A Jelaska, C Zeller, G Kim, U C Broedl, H J Woerle, EMPA-REG BASALTM trial investigators

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 126 papers, 37 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
126citing papers in PubMed, 37 pooled it
24.8field-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

126 citing papers in PubMed, 37 syntheses or guidelines pooled it, 253 citations in OpenAlex.

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66 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 at 3 institutions in 2 countries.

J RosenstockDallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.
A JelaskaBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
C ZellerBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
G KimBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
U C BroedlBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
H J WoerleBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
EMPA-REG BASALTM trial investigators
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United States) · USDallas Diabetes Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the efficacy and tolerability of empagliflozin added to basal insulin-treated type 2 diabetes.

methodsPatients inadequately controlled [glycated haemoglobin (HbA1c) >7 to ≤10% (>53 to ≤86 mmol/mol)] on basal insulin (glargine, detemir, NPH) were randomized to empagliflozin 10 mg (n = 169), empagliflozin 25 mg (n = 155) or placebo (n = 170) for 78 weeks. The baseline characteristics were balanced among the groups [mean HbA1c 8.2% (67 mmol/mol), BMI 32.2 kg/m(2) ]. The basal insulin dose was to remain constant for 18 weeks, then could be adjusted at investigator's discretion. The primary endpoint was change from baseline in HbA1c at week 18. Key secondary endpoints were changes from baseline in HbA1c and insulin dose at week 78.

resultsAt week 18, the adjusted mean ± standard error changes from baseline in HbA1c were 0.0 ± 0.1% (-0.1 ± 0.8 mmol/mol) for placebo, compared with -0.6 ± 0.1% (-6.2 ± 0.8 mmol/mol) and -0.7 ± 0.1% (-7.8 ± 0.8 mmol/mol) for empagliflozin 10 and 25 mg, respectively (both p < 0.001). At week 78, empagliflozin 10 and 25 mg significantly reduced HbA1c, insulin dose and weight vs placebo (all p < 0.01), and empagliflozin 10 mg significantly reduced systolic blood pressure vs placebo (p = 0.004). Similar percentages of patients had confirmed hypoglycaemia in all groups (35-36%). Events consistent with urinary tract infection were reported in 9, 15 and 12% of patients on placebo, empagliflozin 10 and 25 mg, and events consistent with genital infection were reported in 2, 8 and 5%, respectively.

conclusionsEmpagliflozin for 78 weeks added to basal insulin improved glycaemic control and reduced weight with a similar risk of hypoglycaemia to placebo.

Indexed as

AgedBenzhydryl CompoundsBlood GlucoseBlood PressureDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleGlucosidesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin DetemirMaleBenzhydryl CompoundsBlood GlucoseempagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin DetemirempagliflozinSGLT2 inhibitortype 2 diabetes

Identifiers

PMID26040302
PMCPMC5034797
OpenAlexW1847388060

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.