Trial reportDiabetes technology & therapeutics2018

Effect of Canagliflozin on Urinary Albumin Excretion in Japanese Patients with Type 2 Diabetes Mellitus and Microalbuminuria: A Pilot Study.

Takeshi Osonoi, Maki Gouda, Mamiko Kubo, Kenji Arakawa, Toshio Hashimoto, Masanori Abe

Open access · hybridFull text readClinical Trial
In one paragraph

Trial report in Diabetes technology & therapeutics, 2018. The graph read 1 number from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. Cited by 15 papers, 1 of them a synthesis that pooled it.

1number the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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.

Read, but not usablea number the graph found but could not read as for or against

Kidney outcomescomparator not stated · ckd, hypertensionfeeds one cell of the map
decrease -42.0-57.0 to -21.9P = 0.0011
RESULTS: The urinary albumin level decreased by 42.0% (95% confidence interval: 21.9-57.0; P = 0.0011) after 12 weeks of canagliflozin treatment.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

SGLT2 inhibitors×kidney outcomes

No readable resultOpen on the map →What to test next →

13 readable studies in this cell: 10 favour the treatment, 1 find no difference, 2 favour the comparator.

Belief with this paper
0.89established · 8 families support, 1 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
1 · no effect
NCT02864914333,580 enrolled · 2016
IRR 0.690.45 to 1.05
NCT0546531762,197 enrolled · 2022
HR 0.750.65 to 0.86
NCT0173053417,190 enrolled · 2013
HR 0.760.67 to 0.87
NCT030579515,988 enrolled · 2017
Treatment by time interaction 1.360.86 to 1.86
NCT019897545,813 enrolled · 2014
HR 0.640.57 to 0.73
NCT020657914,401 enrolled · 2014
HR 0.700.59 to 0.82
NCT010326294,330 enrolled · 2009
OR 0.800.67 to 0.97
NCT030579773,730 enrolled · 2017
Treatment by time interaction 1.730.67 to 2.80

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

5 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
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6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Takeshi Osonoi1 Department of Internal Medicine, Naka Kinen Clinic , Ibaraki, Japan .
Maki Gouda2 Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation , Tokyo, Japan .
Mamiko Kubo2 Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation , Tokyo, Japan .
Kenji Arakawa2 Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation , Tokyo, Japan .
Toshio Hashimoto2 Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation , Tokyo, Japan .
Masanori Abe3 Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine , Tokyo, Japan .
Mitsubishi Group (Japan) · JPKinan Hospital · JPNihon University · JP

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundAlbuminuria characterizes the progression of kidney injury. The effect of canagliflozin on the excretion of microalbumin was assessed for investigating its renoprotective potential in Japanese patients with type 2 diabetes mellitus (T2DM). PATIENTS AND

methodsTwenty Japanese patients with T2DM and microalbuminuria were enrolled and administered with 100 mg of canagliflozin once a day for 12 weeks. These subjects were admitted to the clinic at the start and end of the treatment period for 24-h urine collection. The primary endpoint was the percentage change in geometric mean 24-h urinary albumin excretion from baseline to week 12.

resultsThe urinary albumin level decreased by 42.0% (95% confidence interval: 21.9-57.0; P = 0.0011) after 12 weeks of canagliflozin treatment. A number of blood and urinary parameters also significantly decreased, including hemoglobin A1c, fasting plasma glucose, estimated glomerular filtration rate, and creatinine clearance, while hematocrit was elevated. Among the biomarkers associated with kidney injury and inflammation, the urinary level of the oxidative stress marker 8-hydroxy-2'-deoxyguanosine was also decreased. There were no meaningful correlations noted between changes in urinary albumin excretion and other parameters/biomarkers. No severe adverse events were reported over the 12-week treatment period.

conclusionsThe results of this study indicate that canagliflozin decreases microalbuminuria in Japanese patients with T2DM. Albuminuria could be reduced as a result of changes in various physiological pathways; therefore, it is imperative that future, large-scale, studies attempt to determine the detailed mechanisms involved. Canagliflozin may offer a novel therapeutic option for Japanese patients with T2DM and incipient nephropathy.

Indexed as

AdultAgedAlbuminuriaAsian PeopleBlood GlucoseBlood PressureBody WeightCanagliflozinDiabetes Mellitus, Type 2Diabetic NephropathiesFemaleGlycated HemoglobinHumansHypoglycemic AgentsKidney Function TestsMaleBlood GlucoseCanagliflozinGlycated HemoglobinHypoglycemic AgentsAlbuminuriaCanagliflozinNephropathyRenoprotective effectSGLT2 inhibitorType 2 diabetes

Identifiers

PMID30096243
PMCPMC6161332
OpenAlexW2886057382

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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.