Evidence map›Paper›PMID 23464594›Full record

Trial reportDiabetes, obesity & metabolism2013

Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease.

J-F Yale, G Bakris, B Cariou, D Yue, E David-Neto, L Xi, K Figueroa, E Wajs, K Usiskin, G Meininger

Registry-linked trialOpen access · bronzeFull text readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02694263 (A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan), which is not on this map. Cited by 211 papers, 25 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
211citing papers in PubMed, 25 pooled it
47.6field-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.

NCT02694263 phase4completedstarted 2016, after this paper: background citation

A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study

Ran2016Enrolled25Registered outcomes32Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsCanagliflozin, Gliclazide, Glimepiride, Pioglitazone, Repaglinide
PMID 24373063PMID 23564919PMID 26203064PMID 23782529PMID 22492586PMID 24026211PMID 23279307PMID 24073995PMID 20508640PMID 22310849PMID 9727886PMID 8888584other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

211 citing papers in PubMed, 25 syntheses or guidelines pooled it, 482 citations in OpenAlex.

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151 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

10 authors at 6 institutions in 5 countries.

J-F YaleDepartment of Medicine, Royal Victoria Hospital and McGill University, Montreal, Canada. jean-francois.yale@mcgill.ca
G Bakris
B Cariou
D Yue
E David-Neto
L Xi
K Figueroa
E Wajs
K Usiskin
G Meininger
Janssen (United States) · USHospital Sírio-Libanês · BRJanssen (Belgium) · BERoyal Victoria Hospital · CAThe University of Sydney · AUUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsCanagliflozin is a sodium glucose co-transporter 2 inhibitor in development for treatment of type 2 diabetes mellitus (T2DM). This study evaluated the efficacy and safety of canagliflozin in subjects with T2DM and stage 3 chronic kidney disease [CKD; estimated glomerular filtration rate (eGFR) ≥30 and <50 ml/min/1.73 m(2)].

methodsIn this randomized, double-blind, placebo-controlled, phase 3 trial, subjects (N = 269) received canagliflozin 100 or 300 mg or placebo daily. The primary efficacy endpoint was change from baseline in HbA1c at week 26. Prespecified secondary endpoints were change in fasting plasma glucose (FPG) and proportion of subjects reaching HbA1c <7.0%. Safety was assessed based on adverse event (AE) reports; renal safety parameters (e.g. eGFR, blood urea nitrogen and albumin/creatinine ratio) were also evaluated.

resultsBoth canagliflozin 100 and 300 mg reduced HbA1c from baseline compared with placebo at week 26 (-0.33, -0.44 and -0.03%; p < 0.05). Numerical reductions in FPG and higher proportions of subjects reaching HbA1c < 7.0% were observed with canagliflozin 100 and 300 mg versus placebo (27.3, 32.6 and 17.2%). Overall AE rates were similar for canagliflozin 100 and 300 mg and placebo (78.9, 74.2 and 74.4%). Slightly higher rates of urinary tract infections and AEs related to osmotic diuresis and reduced intravascular volume were observed with canagliflozin 300 mg compared with other groups. Transient changes in renal function parameters that trended towards baseline over 26 weeks were observed with canagliflozin.

conclusionCanagliflozin improved glycaemic control and was generally well tolerated in subjects with T2DM and Stage 3 CKD.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAgedBiomarkersBlood GlucoseBody WeightCanagliflozinComorbidityDiabetes Mellitus, Type 2Disease ProgressionDiuresisDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGlomerular Filtration RateGlucosidesBiomarkersBlood GlucoseCanagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsSLC5A2 protein, humanSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 InhibitorsThiophenes

Identifiers

PMID23464594
PMCPMC3654568
OpenAlexW2077038286

What Socratic holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

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.