Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled, 12‐week study
Identifieur interne : 001241 ( Istex/Corpus ); précédent : 001240; suivant : 001242Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled, 12‐week study
Auteurs : N. Inagaki ; K. Kondo ; T. Yoshinari ; N. Maruyama ; Y. Susuta ; H. KukiSource :
- Diabetes, Obesity and Metabolism [ 1462-8902 ] ; 2013-12.
Abstract
We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy.
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DOI: 10.1111/dom.12149
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Yoshinari</name><affiliation><mods:affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</mods:affiliation></affiliation><affiliation><mods:affiliation>: Toru Yoshinari, Mitsubishi Tanabe Pharma Corporation, 17–10 Nihonbashi‐Koamicho, Chuo‐ku, Tokyo, Japan.E‐mail:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: yoshinari.toru@mn.mt-pharma.co.jp</mods:affiliation></affiliation></author><author><name sortKey="Maruyama, N" sort="Maruyama, N" uniqKey="Maruyama N" first="N." last="Maruyama">N. Maruyama</name><affiliation><mods:affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Susuta, Y" sort="Susuta, Y" uniqKey="Susuta Y" first="Y." last="Susuta">Y. Susuta</name><affiliation><mods:affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kuki, H" sort="Kuki, H" uniqKey="Kuki H" first="H." last="Kuki">H. 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Inagaki</name><affiliation><mods:affiliation>Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kondo, K" sort="Kondo, K" uniqKey="Kondo K" first="K." last="Kondo">K. Kondo</name><affiliation><mods:affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Yoshinari, T" sort="Yoshinari, T" uniqKey="Yoshinari T" first="T." last="Yoshinari">T. Yoshinari</name><affiliation><mods:affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</mods:affiliation></affiliation><affiliation><mods:affiliation>: Toru Yoshinari, Mitsubishi Tanabe Pharma Corporation, 17–10 Nihonbashi‐Koamicho, Chuo‐ku, Tokyo, Japan.E‐mail:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: yoshinari.toru@mn.mt-pharma.co.jp</mods:affiliation></affiliation></author><author><name sortKey="Maruyama, N" sort="Maruyama, N" uniqKey="Maruyama N" first="N." last="Maruyama">N. Maruyama</name><affiliation><mods:affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Susuta, Y" sort="Susuta, Y" uniqKey="Susuta Y" first="Y." last="Susuta">Y. Susuta</name><affiliation><mods:affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kuki, H" sort="Kuki, H" uniqKey="Kuki H" first="H." last="Kuki">H. Kuki</name><affiliation><mods:affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Diabetes, Obesity and Metabolism</title><title level="j" type="abbrev">Diabetes Obes Metab</title><idno type="ISSN">1462-8902</idno><idno type="eISSN">1463-1326</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2013-12">2013-12</date><biblScope unit="volume">15</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1136">1136</biblScope><biblScope unit="page" to="1145">1145</biblScope></imprint><idno type="ISSN">1462-8902</idno></series><idno type="istex">7CD01016BA2B7C47AEB2F9A2E917D042FC65156C</idno><idno type="DOI">10.1111/dom.12149</idno><idno type="ArticleID">DOM12149</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1462-8902</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>N. Inagaki</name><affiliations><json:string>Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan</json:string></affiliations></json:item><json:item><name>K. Kondo</name><affiliations><json:string>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</json:string></affiliations></json:item><json:item><name>T. Yoshinari</name><affiliations><json:string>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</json:string><json:string>: Toru Yoshinari, Mitsubishi Tanabe Pharma Corporation, 17–10 Nihonbashi‐Koamicho, Chuo‐ku, Tokyo, Japan.E‐mail:</json:string><json:string>E-mail: yoshinari.toru@mn.mt-pharma.co.jp</json:string></affiliations></json:item><json:item><name>N. Maruyama</name><affiliations><json:string>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</json:string></affiliations></json:item><json:item><name>Y. Susuta</name><affiliations><json:string>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</json:string></affiliations></json:item><json:item><name>H. 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Eligibility criteria and the method for sample size calculation are provided in the Supporting Information.Figure S1. HbA1c (A), FPG (B), urinary glucose/creatinine ratio (C) and body weight (D) measured at the start (except for urinary glucose/creatinine ratio and body weight) and end of the run‐in period and during the 12‐week treatment period. HbA1c, haemoglobin A1c; NGSP, National Glycohemoglobin Standardization Program; FPG, fasting plasma glucose; UGE, urinary glucose excretion; CRE, creatinine.Figure S2. Plasma glucose levels measured during the meal tolerance tests performed at baseline (end of the run‐in period) and at week 12 in the treatment period in the placebo (A), 50 mg (B), 100 mg (C), 200 mg (D) and 300 mg (E) canagliflozin groups. The meal was consumed at 0 min.</note><note type="content">*Parts of this study were previously presented as a poster presentation at the 71st Scientific Sessions of the American Diabetes Association, San Diego, CA, USA, 24–28 June, 2011, and at the 9th International Diabetes Federation Western Pacific Region Congress, Kyoto, Japan, November 24–27, 2012.</note><note>Mitsubishi Tanabe Pharma Corporation</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled, 12‐week study</title><author xml:id="author-1"><persName><forename type="first">N.</forename><surname>Inagaki</surname></persName><affiliation>Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan</affiliation></author><author xml:id="author-2"><persName><forename type="first">K.</forename><surname>Kondo</surname></persName><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation></author><author xml:id="author-3"><persName><forename type="first">T.</forename><surname>Yoshinari</surname></persName><email>yoshinari.toru@mn.mt-pharma.co.jp</email><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation><affiliation>: Toru Yoshinari, Mitsubishi Tanabe Pharma Corporation, 17–10 Nihonbashi‐Koamicho, Chuo‐ku, Tokyo, Japan.E‐mail:</affiliation></author><author xml:id="author-4"><persName><forename type="first">N.</forename><surname>Maruyama</surname></persName><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation></author><author xml:id="author-5"><persName><forename type="first">Y.</forename><surname>Susuta</surname></persName><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation></author><author xml:id="author-6"><persName><forename type="first">H.</forename><surname>Kuki</surname></persName><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation></author></analytic><monogr><title level="j">Diabetes, Obesity and Metabolism</title><title level="j" type="abbrev">Diabetes Obes Metab</title><idno type="pISSN">1462-8902</idno><idno type="eISSN">1463-1326</idno><idno type="DOI">10.1111/(ISSN)1463-1326</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2013-12"></date><biblScope unit="volume">15</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1136">1136</biblScope><biblScope unit="page" to="1145">1145</biblScope></imprint></monogr><idno type="istex">7CD01016BA2B7C47AEB2F9A2E917D042FC65156C</idno><idno type="DOI">10.1111/dom.12149</idno><idno type="ArticleID">DOM12149</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013-06-27</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy.</p></abstract><abstract><p>Patients aged 20–80 years with T2DM diagnosed ≥3 months previously, and HbA1c of 6.9–9.9% were randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 12 weeks. The primary and secondary endpoints were changes in HbA1c, fasting plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (AEs) and clinical laboratory tests.</p></abstract><abstract><p>Overall, 383 patients were randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo (−0.61, –0.80, –0.79 and −0.88% for 50, 100, 200 and 300 mg, respectively, versus +0.11% for placebo; all, p < 0.01). FPG and postprandial glycaemic parameters improved significantly in the canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug‐related serious AEs were reported. There was no dose‐dependent increase in the incidence of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio.</p></abstract><abstract><p>Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. Canagliflozin was well tolerated.</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>SGLT2 inhibitor</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>ORIGINAL ARTICLE</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2012-12-18">Received</change><change when="2013-06-11">Registration</change><change when="2013-06-27">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/7CD01016BA2B7C47AEB2F9A2E917D042FC65156C/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:lang="en" xml:id="dom12149"><header xml:id="dom12149-hdr-0001"><publicationMeta level="product"><publisherInfo><publisherName>Blackwell Publishing Ltd</publisherName><publisherLoc>Oxford, UK</publisherLoc></publisherInfo><doi>10.1111/(ISSN)1463-1326</doi><issn type="print">1462-8902</issn><issn type="electronic">1463-1326</issn><idGroup><id type="product" value="DOM"></id></idGroup><titleGroup><title type="main" sort="DIABETES, OBESITY AND METABOLISM">Diabetes, Obesity and Metabolism</title><title type="short">Diabetes Obes Metab</title></titleGroup></publicationMeta><publicationMeta level="part" position="120"><doi origin="wiley">10.1111/dom.2013.15.issue-12</doi><copyright ownership="publisher">© 2013 John Wiley & Sons Ltd</copyright><numberingGroup><numbering type="journalVolume" number="15">15</numbering><numbering type="journalIssue">12</numbering></numberingGroup><coverDate startDate="2013-12">December 2013</coverDate></publicationMeta><publicationMeta level="unit" position="110" type="article" accessType="open" status="forIssue"><doi>10.1111/dom.12149</doi><idGroup><id type="unit" value="DOM12149"></id></idGroup><countGroup><count type="pageTotal" number="10"></count></countGroup><titleGroup><title type="articleCategory">ORIGINAL ARTICLE</title><title type="tocHeading1">ORIGINAL ARTICLES</title></titleGroup><copyright ownership="publisher">© 2013 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</copyright><legalStatement type="creativeCommonsBy-nc"><p>This is an open access article under the terms of the <url href="http://creativecommons.org/licenses/by-nc/3.0/">Creative Commons Attribution‐NonCommercial</url> License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.</p></legalStatement><eventGroup><event type="manuscriptReceived" date="2012-12-18"></event><event type="manuscriptRevised" date="2013-02-04"></event><event type="manuscriptAccepted" date="2013-06-11"></event><event type="xmlCreated" agent="Laserwords Private Ltd." date="2013-06-27"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.2.6 mode:FullText" date="2013-11-05"></event><event type="publishedOnlineAccepted" date="2013-06-19"></event><event type="publishedOnlineEarlyUnpaginated" date="2013-07-14"></event><event type="firstOnline" date="2013-07-14"></event><event type="publishedOnlineFinalForm" date="2013-11-05"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-03"></event></eventGroup><numberingGroup><numbering type="pageFirst">1136</numbering><numbering type="pageLast">1145</numbering></numberingGroup><correspondenceTo><lineatedText><line><i>Correspondence to</i>: Toru Yoshinari, Mitsubishi Tanabe Pharma Corporation, 17–10 Nihonbashi‐Koamicho, Chuo‐ku, Tokyo, Japan.</line><line>E‐mail: <email>yoshinari.toru@mn.mt-pharma.co.jp</email></line></lineatedText></correspondenceTo><objectNameGroup><objectName elementName="appendix">Appendix</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:DOM.DOM12149.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled, 12‐week study<link href="#dom12149-note-0001"></link></title><title type="tocForm">Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled, 12‐week study</title><title type="shortAuthors">Inagaki et al</title></titleGroup><creators><creator creatorRole="author" xml:id="dom12149-cr-0001" affiliationRef="#dom12149-aff-0001"><personName><givenNames>N.</givenNames><familyName>Inagaki</familyName></personName></creator><creator creatorRole="author" xml:id="dom12149-cr-0002" affiliationRef="#dom12149-aff-0002"><personName><givenNames>K.</givenNames><familyName>Kondo</familyName></personName></creator><creator creatorRole="author" xml:id="dom12149-cr-0003" affiliationRef="#dom12149-aff-0002" corresponding="yes"><personName><givenNames>T.</givenNames><familyName>Yoshinari</familyName></personName></creator><creator creatorRole="author" xml:id="dom12149-cr-0004" affiliationRef="#dom12149-aff-0002"><personName><givenNames>N.</givenNames><familyName>Maruyama</familyName></personName></creator><creator creatorRole="author" xml:id="dom12149-cr-0005" affiliationRef="#dom12149-aff-0002"><personName><givenNames>Y.</givenNames><familyName>Susuta</familyName></personName></creator><creator creatorRole="author" xml:id="dom12149-cr-0006" affiliationRef="#dom12149-aff-0002"><personName><givenNames>H.</givenNames><familyName>Kuki</familyName></personName></creator></creators><affiliationGroup xml:id="dom12149-affgp-0001"><affiliation countryCode="JP" type="organization" xml:id="dom12149-aff-0001"><orgDiv>Department of Diabetes and Clinical Nutrition</orgDiv><orgName>Kyoto University Graduate School of Medicine</orgName><address><city>Kyoto</city><country>Japan</country></address></affiliation><affiliation countryCode="JP" type="organization" xml:id="dom12149-aff-0002"><orgName>Mitsubishi Tanabe Pharma Corporation</orgName><address><city>Tokyo</city><country>Japan</country></address></affiliation></affiliationGroup><keywordGroup type="author"><keyword xml:id="dom12149-kwd-0001"><fc>SGLT2</fc> inhibitor</keyword></keywordGroup><fundingInfo><fundingAgency>Mitsubishi Tanabe Pharma Corporation</fundingAgency></fundingInfo><supportingInformation><supportingInfoItem><mediaResource alt="supplementary data" mimeType="application/msword" rendition="webOriginal" href="urn-x:wiley:14628902:media:dom12149:dom12149-sup-0001-AppendixS1"></mediaResource><caption><b>Appendix S1.</b> Eligibility criteria and the method for sample size calculation are provided in the Supporting Information.</caption></supportingInfoItem><supportingInfoItem><mediaResource alt="supplementary data" mimeType="image/tiff" rendition="webOriginal" href="urn-x:wiley:14628902:media:dom12149:dom12149-sup-0002-FigureS1"></mediaResource><caption><b>Figure S1.</b> HbA1c (A), FPG (B), urinary glucose/creatinine ratio (C) and body weight (D) measured at the start (except for urinary glucose/creatinine ratio and body weight) and end of the run‐in period and during the 12‐week treatment period. HbA1c, haemoglobin A1c; NGSP, National Glycohemoglobin Standardization Program; FPG, fasting plasma glucose; UGE, urinary glucose excretion; CRE, creatinine.</caption></supportingInfoItem><supportingInfoItem><mediaResource alt="supplementary data" mimeType="image/tiff" rendition="webOriginal" href="urn-x:wiley:14628902:media:dom12149:dom12149-sup-0003-FigureS2"></mediaResource><caption><b>Figure S2.</b> Plasma glucose levels measured during the meal tolerance tests performed at baseline (end of the run‐in period) and at week 12 in the treatment period in the placebo (A), 50 mg (B), 100 mg (C), 200 mg (D) and 300 mg (E) canagliflozin groups. The meal was consumed at 0 min.</caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:id="dom12149-abs-0001"><section xml:id="dom12149-sec-0001"><title type="main">Aims</title><p xml:id="dom12149-para-0001">We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in Japanese patients with type 2 diabetes (<fc>T2DM</fc>) undergoing diet and exercise therapy.</p></section><section xml:id="dom12149-sec-0002"><title type="main">Methods</title><p xml:id="dom12149-para-0002">Patients aged 20–80 years with <fc>T2DM</fc> diagnosed ≥3 months previously, and <fc>HbA1c</fc> of 6.9–9.9% were randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 12 weeks. The primary and secondary endpoints were changes in <fc>HbA1c</fc>, fasting plasma glucose (<fc>FPG</fc>), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (<fc>AEs</fc>) and clinical laboratory tests.</p></section><section xml:id="dom12149-sec-0003"><title type="main">Results</title><p xml:id="dom12149-para-0003">Overall, 383 patients were randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, significant reductions in <fc>HbA1c</fc> were observed in all canagliflozin groups relative to placebo (−0.61, –0.80, –0.79 and −0.88% for 50, 100, 200 and 300 mg, respectively, versus +0.11% for placebo; all, p < 0.01). <fc>FPG</fc> and postprandial glycaemic parameters improved significantly in the canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug‐related serious <fc>AEs</fc> were reported. There was no dose‐dependent increase in the incidence of <fc>AEs</fc> in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio.</p></section><section xml:id="dom12149-sec-0004"><title type="main">Conclusions</title><p xml:id="dom12149-para-0004">Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with <fc>T2DM</fc>. Canagliflozin was well tolerated.</p></section></abstract></abstractGroup></contentMeta><noteGroup xml:id="dom12149-ntgp-0001"><note xml:id="dom12149-note-0001">Parts of this study were previously presented as a poster presentation at the 71st Scientific Sessions of the American Diabetes Association, San Diego, CA, USA, 24–28 June, 2011, and at the 9th International Diabetes Federation Western Pacific Region Congress, Kyoto, Japan, November 24–27, 2012.</note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled, 12‐week study</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double‐blind, placebo‐controlled, 12‐week study</title></titleInfo><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Inagaki</namePart><affiliation>Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.</namePart><namePart type="family">Kondo</namePart><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T.</namePart><namePart type="family">Yoshinari</namePart><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation><affiliation>: Toru Yoshinari, Mitsubishi Tanabe Pharma Corporation, 17–10 Nihonbashi‐Koamicho, Chuo‐ku, Tokyo, Japan.E‐mail:</affiliation><affiliation>E-mail: yoshinari.toru@mn.mt-pharma.co.jp</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Maruyama</namePart><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Y.</namePart><namePart type="family">Susuta</namePart><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Kuki</namePart><affiliation>Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2013-12</dateIssued><dateCreated encoding="w3cdtf">2013-06-27</dateCreated><dateCaptured encoding="w3cdtf">2012-12-18</dateCaptured><dateValid encoding="w3cdtf">2013-06-11</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>We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy.</abstract><abstract>Patients aged 20–80 years with T2DM diagnosed ≥3 months previously, and HbA1c of 6.9–9.9% were randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 12 weeks. The primary and secondary endpoints were changes in HbA1c, fasting plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (AEs) and clinical laboratory tests.</abstract><abstract>Overall, 383 patients were randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo (−0.61, –0.80, –0.79 and −0.88% for 50, 100, 200 and 300 mg, respectively, versus +0.11% for placebo; all, p < 0.01). FPG and postprandial glycaemic parameters improved significantly in the canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug‐related serious AEs were reported. There was no dose‐dependent increase in the incidence of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio.</abstract><abstract>Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. Canagliflozin was well tolerated.</abstract><note type="additional physical form">Appendix S1. Eligibility criteria and the method for sample size calculation are provided in the Supporting Information.Figure S1. HbA1c (A), FPG (B), urinary glucose/creatinine ratio (C) and body weight (D) measured at the start (except for urinary glucose/creatinine ratio and body weight) and end of the run‐in period and during the 12‐week treatment period. HbA1c, haemoglobin A1c; NGSP, National Glycohemoglobin Standardization Program; FPG, fasting plasma glucose; UGE, urinary glucose excretion; CRE, creatinine.Figure S2. Plasma glucose levels measured during the meal tolerance tests performed at baseline (end of the run‐in period) and at week 12 in the treatment period in the placebo (A), 50 mg (B), 100 mg (C), 200 mg (D) and 300 mg (E) canagliflozin groups. The meal was consumed at 0 min.</note><note type="content">*Parts of this study were previously presented as a poster presentation at the 71st Scientific Sessions of the American Diabetes Association, San Diego, CA, USA, 24–28 June, 2011, and at the 9th International Diabetes Federation Western Pacific Region Congress, Kyoto, Japan, November 24–27, 2012.</note><note type="funding">Mitsubishi Tanabe Pharma Corporation</note><subject><genre>keywords</genre><topic>SGLT2 inhibitor</topic></subject><relatedItem type="host"><titleInfo><title>Diabetes, Obesity and Metabolism</title></titleInfo><titleInfo type="abbreviated"><title>Diabetes Obes Metab</title></titleInfo><genre type="journal">journal</genre><subject><genre>article-category</genre><topic>ORIGINAL ARTICLE</topic></subject><identifier type="ISSN">1462-8902</identifier><identifier type="eISSN">1463-1326</identifier><identifier type="DOI">10.1111/(ISSN)1463-1326</identifier><identifier type="PublisherID">DOM</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>15</number></detail><detail type="issue"><caption>no.</caption><number>12</number></detail><extent unit="pages"><start>1136</start><end>1145</end><total>10</total></extent></part></relatedItem><identifier type="istex">7CD01016BA2B7C47AEB2F9A2E917D042FC65156C</identifier><identifier type="DOI">10.1111/dom.12149</identifier><identifier type="ArticleID">DOM12149</identifier><accessCondition type="use and reproduction" contentType="creativeCommonsBy-nc">This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Blackwell Publishing Ltd</recordOrigin></recordInfo></mods></metadata><enrichments><json:item><type>multicat</type><uri>https://api.istex.fr/document/7CD01016BA2B7C47AEB2F9A2E917D042FC65156C/enrichments/multicat</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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