Evidence map›Paper›PMID 32068914›Full record

Trial reportBritish journal of clinical pharmacology2020

Effects of the dual sodium-glucose linked transporter inhibitor, licogliflozin vs placebo or empagliflozin in patients with type 2 diabetes and heart failure.

Rudolf A de Boer, Julio Núñez, Plamen Kozlovski, Yi Wang, Pieter Proot, Deborah Keefe

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

Trial report in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 11 pooled it
7.5field-weighted citation impact, top 2% 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

27 citing papers in PubMed, 11 syntheses or guidelines pooled it, 66 citations in OpenAlex.

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  17. SGLT2 and SGLT1 inhibitors suppress the activities of the RVLM neurons in newborn Wistar rats.Hypertension research : official journal of the Japanese Society of Hypertension · 2024
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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

6 authors at 4 institutions in 4 countries.

Rudolf A de BoerUniversity of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Julio NúñezServicio de Cardiología, Hospital Clínico Universitario Valencia, València, Spain.
Plamen KozlovskiNovartis Pharma AG, Basel, Switzerland.
Yi WangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Pieter ProotNovartis Pharma AG, Basel, Switzerland.ORCID 0000-0002-0595-794X
Deborah KeefeNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Novartis (Switzerland) · CHNovartis (United States) · USUniversitat de València · ESUniversity Medical Center Groningen · NL

Funding

Novartis Pharma
6 · The paper itself

Abstract

aimsExplore the efficacy, safety and tolerability of the dual sodium-glucose cotransporter (SGLT) 1 and 2 inhibitor, licogliflozin in patients with type-2 diabetes mellitus (T2DM) and heart failure.

methodsThis multicentre, parallel-group phase IIA study randomized 125 patients with T2DM and heart failure (New York Heart Association II-IV; plasma N-terminal pro b-type natriuretic peptide [NT-proBNP] >300 pg/mL) to licogliflozin (2.5 mg, 10 mg, 50 mg) taken at bedtime, empagliflozin (25 mg) or placebo (44 patients completed the study). The primary endpoint was change from baseline in NT-proBNP after 12 weeks. Secondary endpoints included change from baseline in glycated haemoglobin, fasting plasma glucose, weight, blood pressure, fasting lipid profile, high-sensitivity c-reactive protein, and safety and tolerability.

resultsLicogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs placebo (Geometric mean ratio 0.56 [95% confidence interval: 0.33, 0.95], P = .033). A trend was observed with 50 mg licogliflozin (0.64 [95% confidence interval: 0.40, 1.03], P = .064), with no difference between licogliflozin and empagliflozin. The largest numerical decreases in glycated haemoglobin were with licogliflozin 50 mg (-0.58 ± 0.34%) and empagliflozin (-0.44 ± 1.18%) vs placebo (-0.04 ± 0.91%). The reduction in body weight was similar with licogliflozin 50 mg (-2.15 ± 2.40 kg) and empagliflozin (-2.25 ± 1.89 kg). A numerical reduction in systolic blood pressure was seen with licogliflozin 50 mg (-9.54 ± 16.88 mmHg) and empagliflozin (-6.98 ± 15.03 mmHg) vs placebo (-2.85 ± 11.97 mmHg). Adverse events (AEs) were mild, including hypotension (6.5%), hypoglycaemia (8.1%) and inadequate diabetes control (1.6%). The incidence of diarrhoea (4.9%) was lower than previously reported.

conclusionThe reduction in NT-proBNP with licogliflozin suggests a potential benefit of SGLT1 and 2 inhibition in patients with T2DM and heart failure.

Indexed as

Diabetes Mellitus, Type 2Heart FailureAnhydridesBenzhydryl CompoundsBlood GlucoseDouble-Blind MethodGlucoseGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsSodiumSorbitolTreatment OutcomeAnhydridesBenzhydryl CompoundsBlood GlucoseempagliflozinGlucoseGlucosidesGlycated HemoglobinHypoglycemic AgentslicogliflozinSodiumSorbitolbiomarkers, heart failure, pharmacotherapy, type 2 diabetes

Identifiers

PMID32068914
PMCPMC7318993
OpenAlexW3008235903

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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.