Evidence mapPaperPMID 33084149Full record

Trial reportDiabetes, obesity & metabolism2021

Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes.

Silvio E Inzucchi, Melanie J Davies, Kamlesh Khunti, Prabhav Trivedi, Jyothis T George, Isabella Zwiener, Odd Erik Johansen, Naveed Sattar

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 8% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  5. Cost-Effectiveness of Highly Effective Glucose-Lowering Agents: Do Current Practices Optimize Clinical and Economic Outcomes?Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
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  20. Clinical Benefit of Switching from Low-Dose to High-Dose Empagliflozin in Patients with Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
    Article
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

8 authors at 5 institutions in 4 countries.

Silvio E InzucchiYale University School of Medicine, New Haven, Connecticut, USA.ORCID 0000-0003-1254-6636
Melanie J DaviesDiabetes Research Centre, University of Leicester, Leicester, UK.ORCID 0000-0002-9987-9371
Kamlesh KhuntiDiabetes Research Centre, University of Leicester, Leicester, UK.ORCID 0000-0003-2343-7099
Prabhav TrivediBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Jyothis T GeorgeBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Isabella ZwienerBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Odd Erik JohansenBoehringer Ingelheim Norway KS, Asker, Norway.ORCID 0000-0003-2470-0530
Naveed SattarInstitute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.ORCID 0000-0002-1604-2593
Boehringer Ingelheim (Germany) · DEUniversity of Leicester · GBBoehringer Ingelheim (Norway) · NOUniversity of Glasgow · GBYale University · US

Funding

Yale Diabetes Research CenterP30DK045735 · YALE UNIVERSITY · 1993 to 2025
$10.2M
Department of HealthNIDDK NIH HHS P30 DK045735
6 · The paper itself

Abstract

aimTo investigate the association of different categories of baseline cardio-metabolic risk factors on the treatment effects of empagliflozin 10 and 25 mg when added as second-line therapy to metformin in patients with type 2 diabetes (T2D). MATERIALS AND

methodsPatients aged 18 years or older with HbA1c 7.0%-10.0% were included. Analysis of covariance compared change from baseline to weeks 24 and 76 in HbA1c, body weight (BW) and systolic blood pressure (SBP) by respective baseline categories (HbA1c <8.5/≥8.5%; BW <80/80-90/>90 kg, SBP <130/130-140/>140 mmHg). Analyses were also conducted with a model using continuous covariates of cardio-metabolic factors.

resultsIn total, 637 patients (56.7% males; mean [SD] age 55.7 [9.9] years, HbA1c 7.9% [0.9%], BW 81.2 [18.8] kg, SBP 129.4 [14.6] mmHg) received one or more dose of either empagliflozin 10 mg (n = 217) or 25 mg (n = 213), or placebo (n = 207). At both time points, empagliflozin 10/25 mg versus placebo significantly (P < .0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week 24/76 categorical and continuous models: .0290/.1431 and .0004/.0042, respectively) and in BW (P interaction .1340/.0012 and .0202/<.0001, respectively). Both empagliflozin doses also significantly lowered SBP versus placebo at both time points, with similar efficacy by subgroups of baseline SBP. Adverse events were consistent with the established empagliflozin safety profile across treatment groups.

conclusionsEmpagliflozin, as add-on to metformin, decreases HbA1c and BW, particularly in patients with higher HbA1c and BW baseline values, and effectively lowers SBP.

Indexed as

Diabetes Mellitus, Type 2MetforminAgedBenzhydryl CompoundsBlood PressureBody WeightDouble-Blind MethodDrug Therapy, CombinationFemaleGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsMaleMiddle AgedTreatment OutcomeBenzhydryl CompoundsempagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsMetforminbody weightempagliflozinglycaemic controlmetforminSGLT2 inhibitortype 2 diabetes

Identifiers

PMID33084149
PMCPMC7839733
OpenAlexW3093861069

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
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 Socratic graph.