Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial
Identifieur interne : 001606 ( Istex/Corpus ); précédent : 001605; suivant : 001607Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial
Auteurs : J. P. H. Wilding ; G. Charpentier ; P. Hollander ; G. González-Gálvez ; C. Mathieu ; F. Vercruysse ; K. Usiskin ; G. Law ; S. Black ; W. Canovatchel ; G. MeiningerSource :
- International Journal of Clinical Practice [ 1368-5031 ] ; 2013-12.
Abstract
Canagliflozin is a sodium glucose co‐transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM). This randomised, double‐blind, placebo‐controlled, Phase 3 study evaluated the efficacy and safety of canagliflozin as an add‐on to metformin plus sulphonylurea in patients with T2DM.
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DOI: 10.1111/ijcp.12322
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Wilding</name><affiliation><mods:affiliation>Department of Obesity and Endocrinology, University of Liverpool, Liverpool, UK</mods:affiliation></affiliation><affiliation><mods:affiliation>John Wilding, DM, FRCP, Department of Obesity and Endocrinology, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UKTel.: +44(0)151 529 5885Fax: +44(0)151 529 5888Email:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: J.P.H.Wilding@liverpool.ac.uk</mods:affiliation></affiliation></author><author><name sortKey="Charpentier, G" sort="Charpentier, G" uniqKey="Charpentier G" first="G." last="Charpentier">G. 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Wilding</name><affiliation><mods:affiliation>Department of Obesity and Endocrinology, University of Liverpool, Liverpool, UK</mods:affiliation></affiliation><affiliation><mods:affiliation>John Wilding, DM, FRCP, Department of Obesity and Endocrinology, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UKTel.: +44(0)151 529 5885Fax: +44(0)151 529 5888Email:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: J.P.H.Wilding@liverpool.ac.uk</mods:affiliation></affiliation></author><author><name sortKey="Charpentier, G" sort="Charpentier, G" uniqKey="Charpentier G" first="G." last="Charpentier">G. Charpentier</name><affiliation><mods:affiliation>Department of Diabetes Sud‐Francilien Hospital, Centre d'Études et de Recherche pour l'Intensification du Traitement du Diabète (CERITD), Corbeil‐Essonnes, France</mods:affiliation></affiliation></author><author><name sortKey="Hollander, P" sort="Hollander, P" uniqKey="Hollander P" first="P." last="Hollander">P. Hollander</name><affiliation><mods:affiliation>Baylor University Medical Center, TX, Dallas, USA</mods:affiliation></affiliation></author><author><name sortKey="Gonzalez Lvez, G" sort="Gonzalez Lvez, G" uniqKey="Gonzalez Lvez G" first="G." last="González-Gálvez">G. González-Gálvez</name><affiliation><mods:affiliation>Instituto Jalisciense de Investigacion en Diabetes y Obesidad, Guadalajara, Mexico</mods:affiliation></affiliation></author><author><name sortKey="Mathieu, C" sort="Mathieu, C" uniqKey="Mathieu C" first="C." last="Mathieu">C. 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This randomised, double‐blind, placebo‐controlled, Phase 3 study evaluated the efficacy and safety of canagliflozin as an add‐on to metformin plus sulphonylurea in patients with T2DM.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>J. P. H. Wilding</name><affiliations><json:string>Department of Obesity and Endocrinology, University of Liverpool, Liverpool, UK</json:string><json:string>John Wilding, DM, FRCP, Department of Obesity and Endocrinology, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UKTel.: +44(0)151 529 5885Fax: +44(0)151 529 5888Email:</json:string><json:string>E-mail: J.P.H.Wilding@liverpool.ac.uk</json:string></affiliations></json:item><json:item><name>G. 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P. H.</forename><surname>Wilding</surname></persName><email>J.P.H.Wilding@liverpool.ac.uk</email><affiliation>Department of Obesity and Endocrinology, University of Liverpool, Liverpool, UK</affiliation><affiliation>John Wilding, DM, FRCP, Department of Obesity and Endocrinology, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UKTel.: +44(0)151 529 5885Fax: +44(0)151 529 5888Email:</affiliation></author><author xml:id="author-2"><persName><forename type="first">G.</forename><surname>Charpentier</surname></persName><affiliation>Department of Diabetes Sud‐Francilien Hospital, Centre d'Études et de Recherche pour l'Intensification du Traitement du Diabète (CERITD), Corbeil‐Essonnes, France</affiliation></author><author xml:id="author-3"><persName><forename type="first">P.</forename><surname>Hollander</surname></persName><affiliation>Baylor University Medical Center, TX, Dallas, USA</affiliation></author><author xml:id="author-4"><persName><forename type="first">G.</forename><surname>González‐Gálvez</surname></persName><affiliation>Instituto Jalisciense de Investigacion en Diabetes y Obesidad, Guadalajara, Mexico</affiliation></author><author xml:id="author-5"><persName><forename type="first">C.</forename><surname>Mathieu</surname></persName><affiliation>Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium</affiliation></author><author xml:id="author-6"><persName><forename type="first">F.</forename><surname>Vercruysse</surname></persName><affiliation>Janssen Research & Development, Beerse, Belgium</affiliation></author><author xml:id="author-7"><persName><forename type="first">K.</forename><surname>Usiskin</surname></persName><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation></author><author xml:id="author-8"><persName><forename type="first">G.</forename><surname>Law</surname></persName><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation></author><author xml:id="author-9"><persName><forename type="first">S.</forename><surname>Black</surname></persName><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation></author><author xml:id="author-10"><persName><forename type="first">W.</forename><surname>Canovatchel</surname></persName><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation></author><author xml:id="author-11"><persName><forename type="first">G.</forename><surname>Meininger</surname></persName><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation></author></analytic><monogr><title level="j">International Journal of Clinical Practice</title><title level="j" type="abbrev">Int J Clin Pract</title><idno type="pISSN">1368-5031</idno><idno type="eISSN">1742-1241</idno><idno type="DOI">10.1111/(ISSN)1742-1241</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><date type="published" when="2013-12"></date><biblScope unit="volume">67</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1267">1267</biblScope><biblScope unit="page" to="1282">1282</biblScope></imprint></monogr><idno type="istex">4523A0F87E08EB9E953C67E37A8849A67D0E5F2C</idno><idno type="DOI">10.1111/ijcp.12322</idno><idno type="ArticleID">IJCP12322</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013-09-21</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Canagliflozin is a sodium glucose co‐transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM). This randomised, double‐blind, placebo‐controlled, Phase 3 study evaluated the efficacy and safety of canagliflozin as an add‐on to metformin plus sulphonylurea in patients with T2DM.</p></abstract><abstract><p>Patients (N = 469) received canagliflozin 100 or 300 mg or placebo once daily during a 26‐week core period and a 26‐week extension. Prespecified primary end‐point was change in HbA1c at 26 weeks. Secondary end‐points included change in HbA1c at week 52 as well as proportion of patients achieving HbA1c < 7.0%, change in fasting plasma glucose (FPG) and systolic blood pressure, and per cent change in body weight, high‐density lipoprotein cholesterol, and triglycerides (weeks 26 and 52).</p></abstract><abstract><p>HbA1c was significantly reduced with canagliflozin 100 and 300 mg vs. placebo at week 26 (–0.85%, –1.06%, and –0.13%; p < 0.001); these reductions were maintained at week 52 (–0.74%, –0.96%, and 0.01%). Both canagliflozin doses reduced FPG and body weight vs. placebo at week 26 (p < 0.001) and week 52. Overall adverse event (AE) rates were similar across groups over 52 weeks, with higher rates of genital mycotic infections and osmotic diuresis‐related AEs seen with canagliflozin vs. placebo; these led to few discontinuations. Increased incidence of documented, but not severe, hypoglycaemia episodes was seen with canagliflozin vs. placebo.</p></abstract><abstract><p>Canagliflozin improved glycaemic control, reduced body weight, and was generally well tolerated in T2DM patients on metformin plus sulphonylurea over 52 weeks.</p></abstract><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>Original Paper</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2013-04-15">Received</change><change when="2013-09-11">Registration</change><change when="2013-09-21">Created</change><change when="2013-12">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/4523A0F87E08EB9E953C67E37A8849A67D0E5F2C/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component type="serialArticle" version="2.0" xml:id="ijcp12322" xml:lang="en"><header><publicationMeta level="product"><doi origin="wiley" registered="yes">10.1111/(ISSN)1742-1241</doi><issn type="print">1368-5031</issn><issn type="electronic">1742-1241</issn><idGroup><id type="product" value="IJCP"></id></idGroup><titleGroup><title sort="INTERNATIONAL JOURNAL OF CLINICAL PRACTICE" type="main">International Journal of Clinical Practice</title><title type="short">Int J Clin Pract</title></titleGroup></publicationMeta><publicationMeta level="part" position="12112"><doi origin="wiley">10.1111/ijcp.2013.67.issue-12</doi><copyright ownership="publisher">Copyright © 2013 John Wiley & Sons Ltd</copyright><numberingGroup><numbering type="journalVolume" number="67">67</numbering><numbering type="journalIssue">12</numbering></numberingGroup><coverDate startDate="2013-12">December 2013</coverDate></publicationMeta><publicationMeta level="unit" position="120" status="forIssue" type="article" accessType="open"><doi>10.1111/ijcp.12322</doi><idGroup><id type="unit" value="IJCP12322"></id></idGroup><countGroup><count number="16" type="pageTotal"></count></countGroup><titleGroup><title type="articleCategory">Original Paper</title><title type="tocHeading1">Endocrinology</title></titleGroup><copyright ownership="publisher">© 2013 The Authors International Journal of Clinical Practice Published by John Wiley & Sons Ltd</copyright><legalStatement type="creativeCommonsBy-nc-nd"><p>This is an open access article under the terms of the <url href="http://creativecommons.org/licenses/by-nc-nd/3.0/">Creative Commons Attribution‐NonCommercial‐NoDerivs</url> License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.</p></legalStatement><eventGroup><event date="2013-04-15" type="manuscriptReceived"></event><event date="2013-09-11" type="manuscriptAccepted"></event><event agent="SPS" date="2013-09-21" type="xmlCreated"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.2.6 mode:FullText" date="2013-11-19"></event><event type="publishedOnlineEarlyUnpaginated" date="2013-10-13"></event><event type="firstOnline" date="2013-10-13"></event><event type="publishedOnlineFinalForm" date="2013-11-19"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-04"></event></eventGroup><numberingGroup><numbering type="pageFirst">1267</numbering><numbering type="pageLast">1282</numbering></numberingGroup><correspondenceTo><lineatedText><line><b>Correspondence to:</b></line><line>John Wilding, DM, FRCP, Department of Obesity and Endocrinology, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UK</line><line>Tel.: +44(0)151 529 5885</line><line>Fax: +44(0)151 529 5888</line><line>Email: <email>J.P.H.Wilding@liverpool.ac.uk</email></line></lineatedText></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:IJCP.IJCP12322.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial</title></titleGroup><creators><creator affiliationRef="#ijcp12322-aff-0001" corresponding="yes" creatorRole="author" xml:id="ijcp12322-cr-0001"><personName><givenNames>J. P. H.</givenNames> <familyName>Wilding</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0002" creatorRole="author" xml:id="ijcp12322-cr-0002"><personName><givenNames>G.</givenNames> <familyName>Charpentier</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0003" creatorRole="author" xml:id="ijcp12322-cr-0003"><personName><givenNames>P.</givenNames> <familyName>Hollander</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0004" creatorRole="author" xml:id="ijcp12322-cr-0004"><personName><givenNames>G.</givenNames> <familyName>González‐Gálvez</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0005" creatorRole="author" xml:id="ijcp12322-cr-0005"><personName><givenNames>C.</givenNames> <familyName>Mathieu</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0006" creatorRole="author" xml:id="ijcp12322-cr-0006"><personName><givenNames>F.</givenNames> <familyName>Vercruysse</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0007" creatorRole="author" xml:id="ijcp12322-cr-0007"><personName><givenNames>K.</givenNames> <familyName>Usiskin</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0007" creatorRole="author" xml:id="ijcp12322-cr-0008"><personName><givenNames>G.</givenNames> <familyName>Law</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0007" creatorRole="author" xml:id="ijcp12322-cr-0009"><personName><givenNames>S.</givenNames> <familyName>Black</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0007" creatorRole="author" xml:id="ijcp12322-cr-0010"><personName><givenNames>W.</givenNames> <familyName>Canovatchel</familyName></personName></creator><creator affiliationRef="#ijcp12322-aff-0007" creatorRole="author" xml:id="ijcp12322-cr-0011"><personName><givenNames>G.</givenNames> <familyName>Meininger</familyName></personName></creator></creators><affiliationGroup><affiliation countryCode="GB" type="organization" xml:id="ijcp12322-aff-0001"><orgDiv>Department of Obesity and Endocrinology</orgDiv> <orgName>University of Liverpool</orgName> <address><city>Liverpool</city> <country>UK</country></address></affiliation><affiliation countryCode="FR" type="organization" xml:id="ijcp12322-aff-0002"><orgDiv>Department of Diabetes Sud‐Francilien Hospital</orgDiv> <orgName>Centre d'Études et de Recherche pour l'Intensification du Traitement du Diabète (CERITD)</orgName> <address><city>Corbeil‐Essonnes</city> <country>France</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="ijcp12322-aff-0003"><orgName>Baylor University Medical Center</orgName> <address><city>Dallas</city> <countryPart>TX</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="MX" type="organization" xml:id="ijcp12322-aff-0004"><orgName>Instituto Jalisciense de Investigacion en Diabetes y Obesidad</orgName> <address><city>Guadalajara</city> <country>Mexico</country></address></affiliation><affiliation countryCode="BE" type="organization" xml:id="ijcp12322-aff-0005"><orgDiv>Clinical and Experimental Endocrinology</orgDiv> <orgName>KU Leuven</orgName> <address><city>Leuven</city> <country>Belgium</country></address></affiliation><affiliation countryCode="BE" type="organization" xml:id="ijcp12322-aff-0006"><orgName>Janssen Research & Development</orgName> <address><city>Beerse</city> <country>Belgium</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="ijcp12322-aff-0007"><orgName>Janssen Research & Development LLC</orgName> <address><city>Raritan</city> <countryPart>NJ</countryPart> <country>USA</country></address></affiliation></affiliationGroup><fundingInfo><fundingAgency>Janssen Research & Development, LLC</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:id="ijcp12322-abs-0001"><title type="main">Summary</title><section xml:id="ijcp12322-sec-0001"><title type="main">Aims</title><p>Canagliflozin is a sodium glucose co‐transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2<fc>DM</fc>). This randomised, double‐blind, placebo‐controlled, Phase 3 study evaluated the efficacy and safety of canagliflozin as an add‐on to metformin plus sulphonylurea in patients with T2<fc>DM</fc>.</p></section><section xml:id="ijcp12322-sec-0002"><title type="main">Methods</title><p>Patients (<i>N</i> = 469) received canagliflozin 100 or 300 mg or placebo once daily during a 26‐week core period and a 26‐week extension. Prespecified primary end‐point was change in HbA<sub>1c</sub> at 26 weeks. Secondary end‐points included change in HbA<sub>1c</sub> at week 52 as well as proportion of patients achieving HbA<sub>1c</sub> < 7.0%, change in fasting plasma glucose (<fc>FPG</fc>) and systolic blood pressure, and per cent change in body weight, high‐density lipoprotein cholesterol, and triglycerides (weeks 26 and 52).</p></section><section xml:id="ijcp12322-sec-0003"><title type="main">Results</title><p>HbA<sub>1c</sub> was significantly reduced with canagliflozin 100 and 300 mg vs. placebo at week 26 (–0.85%, –1.06%, and –0.13%; p<i> </i><<i> </i>0.001); these reductions were maintained at week 52 (–0.74%, –0.96%, and 0.01%). Both canagliflozin doses reduced <fc>FPG</fc> and body weight vs. placebo at week 26 (p<i> </i><<i> </i>0.001) and week 52. Overall adverse event (<fc>AE</fc>) rates were similar across groups over 52 weeks, with higher rates of genital mycotic infections and osmotic diuresis‐related <fc>AE</fc>s seen with canagliflozin vs. placebo; these led to few discontinuations. Increased incidence of documented, but not severe, hypoglycaemia episodes was seen with canagliflozin vs. placebo.</p></section><section xml:id="ijcp12322-sec-0004"><title type="main">Conclusions</title><p>Canagliflozin improved glycaemic control, reduced body weight, and was generally well tolerated in T2<fc>DM</fc> patients on metformin plus sulphonylurea over 52 weeks.</p></section></abstract></abstractGroup></contentMeta><noteGroup xml:id="ijcp12322-ntgp-0001"><note numbered="no" xml:id="ijcp12322-note-0001"><b>Clinical Trial Registration Number:</b> ClinicalTrials.gov, NCT01106625.</note><note numbered="no" xml:id="ijcp12322-note-0002"><p><b>Disclosures</b></p><p>F.V., K.U., G.L., S.B., W.C., and G.M. are full‐time employees of Janssen Research & Development, LLC. J.W. has served as a consultant for Astellas, AstraZeneca, Bristol‐Myers Squibb, Janssen, Novo Nordisk, and Pfizer; has served as a speaker for AstraZeneca, Bristol‐Myers Squibb, Janssen, Eli Lilly, and Novo Nordisk; and has received research support from AstraZeneca, Eli Lilly, Novo Nordisk, and Merck Sharpe and Dohme. G.C. is a member of the French canagliflozin board. P.H. has served on advisory boards and as a consultant for Novo Nordisk, Sanofi, and Merck. G.G. has served as a consultant for Merck Sharpe and Dohme, Novo Nordisk, Bristol‐Myers Squibb, Roche, Boehringer Ingelheim, Eli Lilly, Janssen, and Sanofi; and has served as a speaker for Merck Sharpe and Dohme, Roche, Boehringer Ingelheim, Novo Nordisk, Eli Lilly, Sanofi, Bristol‐Myers Squibb, and Novartis. C.M. has served on advisory panels for Bristol‐Myers Squibb, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharpe and Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi‐Aventis; and has served as a speaker and received research support from Eli Lilly, Merck Sharpe and Dohme, Novartis, Novo Nordisk, and Sanofi‐Aventis.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial</title></titleInfo><name type="personal"><namePart type="given">J. P. H.</namePart><namePart type="family">Wilding</namePart><affiliation>Department of Obesity and Endocrinology, University of Liverpool, Liverpool, UK</affiliation><affiliation>John Wilding, DM, FRCP, Department of Obesity and Endocrinology, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UKTel.: +44(0)151 529 5885Fax: +44(0)151 529 5888Email:</affiliation><affiliation>E-mail: J.P.H.Wilding@liverpool.ac.uk</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Charpentier</namePart><affiliation>Department of Diabetes Sud‐Francilien Hospital, Centre d'Études et de Recherche pour l'Intensification du Traitement du Diabète (CERITD), Corbeil‐Essonnes, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Hollander</namePart><affiliation>Baylor University Medical Center, TX, Dallas, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">González‐Gálvez</namePart><affiliation>Instituto Jalisciense de Investigacion en Diabetes y Obesidad, Guadalajara, Mexico</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Mathieu</namePart><affiliation>Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">F.</namePart><namePart type="family">Vercruysse</namePart><affiliation>Janssen Research & Development, Beerse, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.</namePart><namePart type="family">Usiskin</namePart><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Law</namePart><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Black</namePart><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Canovatchel</namePart><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Meininger</namePart><affiliation>Janssen Research & Development LLC, NJ, Raritan, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><dateIssued encoding="w3cdtf">2013-12</dateIssued><dateCreated encoding="w3cdtf">2013-09-21</dateCreated><dateCaptured encoding="w3cdtf">2013-04-15</dateCaptured><dateValid encoding="w3cdtf">2013-09-11</dateValid><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Canagliflozin is a sodium glucose co‐transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM). This randomised, double‐blind, placebo‐controlled, Phase 3 study evaluated the efficacy and safety of canagliflozin as an add‐on to metformin plus sulphonylurea in patients with T2DM.</abstract><abstract>Patients (N = 469) received canagliflozin 100 or 300 mg or placebo once daily during a 26‐week core period and a 26‐week extension. Prespecified primary end‐point was change in HbA1c at 26 weeks. Secondary end‐points included change in HbA1c at week 52 as well as proportion of patients achieving HbA1c < 7.0%, change in fasting plasma glucose (FPG) and systolic blood pressure, and per cent change in body weight, high‐density lipoprotein cholesterol, and triglycerides (weeks 26 and 52).</abstract><abstract>HbA1c was significantly reduced with canagliflozin 100 and 300 mg vs. placebo at week 26 (–0.85%, –1.06%, and –0.13%; p < 0.001); these reductions were maintained at week 52 (–0.74%, –0.96%, and 0.01%). Both canagliflozin doses reduced FPG and body weight vs. placebo at week 26 (p < 0.001) and week 52. Overall adverse event (AE) rates were similar across groups over 52 weeks, with higher rates of genital mycotic infections and osmotic diuresis‐related AEs seen with canagliflozin vs. placebo; these led to few discontinuations. Increased incidence of documented, but not severe, hypoglycaemia episodes was seen with canagliflozin vs. placebo.</abstract><abstract>Canagliflozin improved glycaemic control, reduced body weight, and was generally well tolerated in T2DM patients on metformin plus sulphonylurea over 52 weeks.</abstract><note type="funding">Janssen Research & Development, LLC</note><relatedItem type="host"><titleInfo><title>International Journal of Clinical Practice</title></titleInfo><titleInfo type="abbreviated"><title>Int J Clin Pract</title></titleInfo><genre type="journal">journal</genre><subject><genre>article-category</genre><topic>Original Paper</topic></subject><identifier type="ISSN">1368-5031</identifier><identifier type="eISSN">1742-1241</identifier><identifier type="DOI">10.1111/(ISSN)1742-1241</identifier><identifier type="PublisherID">IJCP</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>67</number></detail><detail type="issue"><caption>no.</caption><number>12</number></detail><extent unit="pages"><start>1267</start><end>1282</end><total>16</total></extent></part></relatedItem><identifier type="istex">4523A0F87E08EB9E953C67E37A8849A67D0E5F2C</identifier><identifier type="DOI">10.1111/ijcp.12322</identifier><identifier type="ArticleID">IJCP12322</identifier><accessCondition type="use and reproduction" contentType="creativeCommonsBy-nc-nd">This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><enrichments><json:item><type>multicat</type><uri>https://api.istex.fr/document/4523A0F87E08EB9E953C67E37A8849A67D0E5F2C/enrichments/multicat</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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