Evidence map›Paper›PMID 41582689›Full record

Trial reportDiabetes, obesity & metabolism2026

Effect of empagliflozin on urinary albumin excretion and hypoxic biomarkers in early diabetic kidney disease: A randomised double-blind, placebo-controlled trial.

Hisashi Makino, Masato Kasahara, Ryuzo Takashima, Shu Kasama, Naoki Ozu, Hyohun Park, Qingxing Chen, Kazuhiko Tsuruya, Mayu Tochiya, Yoko Omura-Ohata and 5 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Hisashi MakinoDivision of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.ORCID 0000-0001-9953-3736
Masato KasaharaInstitute for Clinical and Translational Science, Nara Medical University Hospital, Kashihara, Nara, Japan.
Ryuzo TakashimaInstitute for Clinical and Translational Science, Nara Medical University Hospital, Kashihara, Nara, Japan.
Shu KasamaInstitute for Clinical and Translational Science, Nara Medical University Hospital, Kashihara, Nara, Japan.
Naoki OzuInstitute for Clinical and Translational Science, Nara Medical University Hospital, Kashihara, Nara, Japan.ORCID 0009-0004-8790-587X
Hyohun ParkDepartment of Internal Medicine, Kyowakai Hospital, Suita, Osaka, Japan.
Qingxing ChenDepartment of Diabetes and Endocrinology, Takatsuki General Hospital, Takatsuki, Osaka, Japan.
Kazuhiko TsuruyaDepartment of Nephrology, Nara Medical University, Kashihara, Nara, Japan.
Mayu TochiyaDivision of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Yoko Omura-OhataDivision of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Tamiko TamanahaDivision of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Michio NoguchiDivision of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Takeshi AibaDivision of Arrhythmia, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Fumiki YoshiharaDivision of Nephrology and Hypertension, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Kiminori HosodaDivision of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.

Funding

Boehringer IngelheimEli Lilly and Company
6 · The paper itself

Abstract

aimsThe precise mechanism of sodium glucose co-transporter 2 (SGLT2) inhibitor on reno-protective effect has been still unclear. In this study, we hypothesised that SGLT2 inhibitor prevents diabetic kidney disease via reduction of hypoxia-induced factors. MATERIALS AND

methodsIn this multicenter, prospective, randomised, double blinded clinical trial, people with type 2 diabetes and microalbuminuria were randomised equally to empagliflozin (10 mg/day) (n = 40) and placebo (n = 39) and followed 24 weeks. The primary endpoint was change in urinary albumin creatinine ratio (ACR) and urinary liver type fatty acid binding protein (L-FABP) excretion from baseline to 24 weeks. Major secondary outcome was change in serum vascular endothelial growth factor (VEGF), angiopoietin-like proteins 2 (ANGPTL2), angiopoietin-like proteins 4 (ANGPTL4), and adrenomedullin (AM) levels.

resultsAlthough the reduction of ACR was significantly greater in the empagliflozin group than the placebo group at 4 and 12 weeks, the difference of change at 24 weeks between the two groups was not statistically significant (Empagliflozin group-Placebo group: -0.3643, 95% CI: -0.7571 to 0.0285, p = 0.0686). There was no difference in urinary L-FABP excretion between the empagliflozin and placebo groups. Serum VEGF and ANGPTL2 decreased significantly more in the empagliflozin group, whereas there were no significant differences in AM and ANGPTL4.

conclusionsThese results demonstrated that empagliflozin partially suppressed the hypoxia-induced angiogenic factors overproduction in addition to a declining trend in ACR in the early stage of diabetic kidney disease, which might contribute to the mechanisms of reno-protective effects of this agent (jRCTs051200147).

Indexed as

AlbuminuriaBenzhydryl CompoundsDiabetes Mellitus, Type 2Diabetic NephropathiesGlucosidesSodium-Glucose Transporter 2 InhibitorsAgedAngiopoietin-Like Protein 2Angiopoietin-Like Protein 4Angiopoietin-like ProteinsBiomarkersDouble-Blind MethodFatty Acid-Binding ProteinsFemaleHumansHypoxiaAngiopoietin-Like Protein 2Angiopoietin-Like Protein 4Angiopoietin-like ProteinsANGPTL2 protein, humanBenzhydryl CompoundsBiomarkersempagliflozinFABP1 protein, humanFatty Acid-Binding ProteinsGlucosidesSodium-Glucose Transporter 2 InhibitorsVascular Endothelial Growth Factor Aclinical trialdiabetic nephropathyempagliflozinrandomised trialtype 2 diabetes

Identifiers

PMID41582689
PMCPMC12992208

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LicenceCC BY-NC-ND
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Registered trials

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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.