Evidence map›Paper›PMID 23279307›Full record

Trial reportDiabetes, obesity & metabolism2013

Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise.

K Stenlöf, W T Cefalu, K-A Kim, M Alba, K Usiskin, C Tong, W Canovatchel, G Meininger

Registry-linked trialFull 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 248 papers, 29 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
248citing papers in PubMed, 29 pooled it
–field-weighted citation impact
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 23464594PMID 24073995PMID 23589542PMID 9727886PMID 8888584PMID 3571496other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

248 citing papers in PubMed, 29 syntheses or guidelines pooled it.

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  11. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
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188 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

8 authors.

K StenlöfClinical Trial Center, Sahlgrenska University Hospital, Gothenburg, Sweden. kaj.stenlof@gu.se
W T Cefalu
K-A Kim
M Alba
K Usiskin
C Tong
W Canovatchel
G Meininger

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 type 2 diabetes mellitus (T2DM). The efficacy and safety of canagliflozin were evaluated in subjects with T2DM inadequately controlled with diet and exercise.

methodsIn this 26-week, randomized, double-blind, placebo-controlled, phase 3 trial, subjects (N = 584) received canagliflozin 100 or 300 mg or placebo once daily. Primary endpoint was the change from baseline in haemoglobin A1c (HbA1c) at week 26. Secondary endpoints included the proportion of subjects achieving HbA1c < 7.0%; change from baseline in fasting plasma glucose (FPG), 2-h postprandial glucose (PPG) and systolic blood pressure (BP); and percent change in body weight, high-density lipoprotein cholesterol (HDL-C) and triglycerides. Adverse events (AEs) were recorded throughout the study.

resultsAt week 26, HbA1c was significantly reduced from baseline with canagliflozin 100 and 300 mg compared with placebo (-0.77, -1.03 and 0.14%, respectively; p < 0.001 for both). Both canagliflozin doses significantly decreased FPG, 2-h PPG, body weight and systolic BP (p < 0.001 for all), and increased HDL-C compared with placebo (p < 0.01 for both). Overall incidences of AEs were modestly higher with canagliflozin versus placebo; rates of serious AEs and AE-related discontinuations were low and similar across groups. Incidences of genital mycotic infections, urinary tract infections and osmotic diuresis-related AEs were higher with canagliflozin; these led to few discontinuations. The incidence of hypoglycaemia was low across groups.

conclusionCanagliflozin treatment improved glycaemic control, reduced body weight and was generally well tolerated in subjects with T2DM inadequately controlled with diet and exercise.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAdolescentAdultAgedAged, 80 and overBlood GlucoseCanagliflozinCholesterol, HDLDiabetes Mellitus, Type 2DietDouble-Blind MethodExerciseFastingFemaleGlucosidesHumansBlood GlucoseCanagliflozinCholesterol, HDLGlucosidesHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsThiophenesTriglycerides

Identifiers

PMID23279307
PMCPMC3593184

What Socratic holds

Textfull text, public
LicenceCC BY
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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.