Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial
Identifieur interne : 000C92 ( Istex/Corpus ); précédent : 000C91; suivant : 000C93Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial
Auteurs : H. W. Rodbard ; B. Cariou ; B. Zinman ; Y. Handelsman ; A. Philis-Tsimikas ; T. V. Skj Th ; A. Rana ; C. MathieuSource :
- Diabetic Medicine [ 0742-3071 ] ; 2013-11.
Abstract
The aim of this study was to compare long‐term safety and efficacy of the basal insulin analogue degludec with glargine in insulin‐naive subjects with Type 2 diabetes.
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DOI: 10.1111/dme.12303
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Handelsman</name><affiliation><mods:affiliation>Metabolic Institute of America, CA, Tarzana, USA</mods:affiliation></affiliation></author><author><name sortKey="Philis Simikas, A" sort="Philis Simikas, A" uniqKey="Philis Simikas A" first="A." last="Philis-Tsimikas">A. Philis-Tsimikas</name><affiliation><mods:affiliation>Scripps Whittier Diabetes Institute, CA, La Jolla, USA</mods:affiliation></affiliation></author><author><name sortKey="Skj Th, T V" sort="Skj Th, T V" uniqKey="Skj Th T" first="T. V." last="Skj Th">T. V. Skj Th</name><affiliation><mods:affiliation>Novo Nordisk A/S, Søborg, Denmark</mods:affiliation></affiliation></author><author><name sortKey="Rana, A" sort="Rana, A" uniqKey="Rana A" first="A." last="Rana">A. Rana</name><affiliation><mods:affiliation>Novo Nordisk A/S, Søborg, Denmark</mods:affiliation></affiliation></author><author><name sortKey="Mathieu, C" sort="Mathieu, C" uniqKey="Mathieu C" first="C." last="Mathieu">C. Mathieu</name><affiliation><mods:affiliation>UZ Leuven, University of Leuven, Leuven, Belgium</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Diabetic Medicine</title><title level="j" type="abbrev">Diabet. Med.</title><idno type="ISSN">0742-3071</idno><idno type="eISSN">1464-5491</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><date type="published" when="2013-11">2013-11</date><biblScope unit="volume">30</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1298">1298</biblScope><biblScope unit="page" to="1304">1304</biblScope></imprint><idno type="ISSN">0742-3071</idno></series><idno type="istex">A28BE9CAC594110081CCE842562F5BA985891B2C</idno><idno type="DOI">10.1111/dme.12303</idno><idno type="ArticleID">DME12303</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0742-3071</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">The aim of this study was to compare long‐term safety and efficacy of the basal insulin analogue degludec with glargine in insulin‐naive subjects with Type 2 diabetes.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>H. 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Rana</name><affiliations><json:string>Novo Nordisk A/S, Søborg, Denmark</json:string></affiliations></json:item><json:item><name>C. Mathieu</name><affiliations><json:string>UZ Leuven, University of Leuven, Leuven, Belgium</json:string></affiliations></json:item></author><articleId><json:string>DME12303</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>shortCommunication</json:string></originalGenre><qualityIndicators><score>6.082</score><pdfVersion>1.7</pdfVersion><pdfPageSize>595.276 x 782.362 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>167</abstractCharCount><pdfWordCount>3770</pdfWordCount><pdfCharCount>25029</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>26</abstractWordCount></qualityIndicators><title>Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial</title><corporate><json:item><name>The BEGIN Once Long Trial Investigators</name></json:item></corporate><genre><json:string>brief-communication</json:string></genre><host><volume>30</volume><publisherId><json:string>DME</json:string></publisherId><pages><total>7</total><last>1304</last><first>1298</first></pages><issn><json:string>0742-3071</json:string></issn><issue>11</issue><subject><json:item><value>Short Report: Treatment</value></json:item></subject><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1464-5491</json:string></eissn><title>Diabetic Medicine</title><doi><json:string>10.1111/(ISSN)1464-5491</json:string></doi></host><publicationDate>2013</publicationDate><copyrightDate>2013</copyrightDate><doi><json:string>10.1111/dme.12303</json:string></doi><id>A28BE9CAC594110081CCE842562F5BA985891B2C</id><score>0.2545726</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/A28BE9CAC594110081CCE842562F5BA985891B2C/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/A28BE9CAC594110081CCE842562F5BA985891B2C/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/A28BE9CAC594110081CCE842562F5BA985891B2C/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Blackwell Publishing Ltd</publisher><availability status="free"><p>Open Access</p></availability><date>2013-08-17</date></publicationStmt><notesStmt><note>Table S1. Participants meeting withdrawal criteria in extension study. Table S2. Demographic and baseline characteristics. Appendix S1. List of investigators in the BEGIN™ Once Long study.</note><note>Novo Nordisk</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial</title><author><orgName>The BEGIN Once Long Trial Investigators</orgName></author><author xml:id="author-1"><persName><forename type="first">H. W.</forename><surname>Rodbard</surname></persName><note type="biography">: Helena W. Rodbard. E‐mail:</note><affiliation>: Helena W. Rodbard. E‐mail:</affiliation><affiliation>Endocrine and Metabolic Consultants, MD, Rockville, USA</affiliation></author><author xml:id="author-2"><persName><forename type="first">B.</forename><surname>Cariou</surname></persName><affiliation>Clinique d'Endocrinologie, l'Institut du Thorax, Nantes, CHU Nantes, France</affiliation></author><author xml:id="author-3"><persName><forename type="first">B.</forename><surname>Zinman</surname></persName><affiliation>Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, ON, Toronto, Canada</affiliation></author><author xml:id="author-4"><persName><forename type="first">Y.</forename><surname>Handelsman</surname></persName><affiliation>Metabolic Institute of America, CA, Tarzana, USA</affiliation></author><author xml:id="author-5"><persName><forename type="first">A.</forename><surname>Philis‐Tsimikas</surname></persName><affiliation>Scripps Whittier Diabetes Institute, CA, La Jolla, USA</affiliation></author><author xml:id="author-6"><persName><forename type="first">T. V.</forename><surname>Skjøth</surname></persName><affiliation>Novo Nordisk A/S, Søborg, Denmark</affiliation></author><author xml:id="author-7"><persName><forename type="first">A.</forename><surname>Rana</surname></persName><affiliation>Novo Nordisk A/S, Søborg, Denmark</affiliation></author><author xml:id="author-8"><persName><forename type="first">C.</forename><surname>Mathieu</surname></persName><affiliation>UZ Leuven, University of Leuven, Leuven, Belgium</affiliation></author></analytic><monogr><title level="j">Diabetic Medicine</title><title level="j" type="abbrev">Diabet. Med.</title><idno type="pISSN">0742-3071</idno><idno type="eISSN">1464-5491</idno><idno type="DOI">10.1111/(ISSN)1464-5491</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><date type="published" when="2013-11"></date><biblScope unit="volume">30</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1298">1298</biblScope><biblScope unit="page" to="1304">1304</biblScope></imprint></monogr><idno type="istex">A28BE9CAC594110081CCE842562F5BA985891B2C</idno><idno type="DOI">10.1111/dme.12303</idno><idno type="ArticleID">DME12303</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013-08-17</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>The aim of this study was to compare long‐term safety and efficacy of the basal insulin analogue degludec with glargine in insulin‐naive subjects with Type 2 diabetes.</p></abstract><abstract><p>This open‐label trial included a 52‐week core period followed by a 52‐week extension. Participants were randomized 3:1 to once‐daily degludec or glargine, administered with metformin ± dipeptidyl peptidase‐4 inhibitors. Basal insulin was titrated to target pre‐breakfast plasma glucose 3.9–4.9 mmol/l.</p></abstract><abstract><p>At end of treatment (104 weeks), mean HbA1c reductions were similar for degludec and glargine; estimated treatment difference between degludec and glargine was 1 mmol/mol (95% CI −1 to 3) [0.07% (95% CI −0.07 to 0.22)], P = 0.339 in the extension trial set (degludec 551, glargine 174), comprising subjects who completed core trial and continued into the extension trial. Overall confirmed hypoglycaemia rates (1.72 vs. 2.05 episodes/patient‐year), rates of adverse events possibly or probably related to trial product (0.19 events/patient‐year), weight gain (2.7 vs. 2.4 kg) and mean daily insulin doses (0.63 U/kg) were similar between treatments in the safety analysis set (degludec 766, glargine 257) comprising all treated subjects. Rates of nocturnal confirmed hypoglycaemia (0.27 vs. 0.46 episodes/patient‐year; P = 0.002) and severe hypoglycaemia (0.006 vs. 0.021 episodes/patient‐year, P = 0.023) were significantly lower with degludec for the safety analysis set (analysis based on intention‐to‐treat full analysis set comprising all randomized subjects).</p></abstract><abstract><p>In Type 2 diabetes, insulin degludec in combination with oral anti‐diabetic drugs, safely and effectively improves long‐term glycaemic control, with a significantly lower risk of nocturnal hypoglycaemia as compared with glargine.</p></abstract><abstract style="short"><p>Insulin degludec, a basal insulin analogue, uses a novel protraction mechanism, resulting in a flat, stable profile and a duration of action greater than 42 h. Consistent with its pharmacokinetic and pharmacodynamic profile, insulin degludec in combination with oral anti‐diabetic drugs provided long‐term glycaemic control similar to insulin glargine with a lower risk for nocturnal hypoglycaemia in insulin‐naive patients with Type 2 diabetes, in a 1‐year, randomized study. This extension study reports 2‐year data, confirming that insulin degludec in combination with oral anti‐diabetic drugs maintains stable glycaemic control with a sustained benefit in reducing hypoglycaemic risk in Type 2 diabetes.</p></abstract><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>Short Report: Treatment</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2013-08-12">Registration</change><change when="2013-08-17">Created</change><change when="2013-11">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/A28BE9CAC594110081CCE842562F5BA985891B2C/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="dme12303" xml:lang="en"><header><publicationMeta level="product"><doi origin="wiley" registered="yes">10.1111/(ISSN)1464-5491</doi><issn type="print">0742-3071</issn><issn type="electronic">1464-5491</issn><idGroup><id type="product" value="DME"></id></idGroup><titleGroup><title sort="DIABETIC MEDICINE" type="main">Diabetic Medicine</title><title type="short">Diabet. Med.</title></titleGroup></publicationMeta><publicationMeta level="part" position="11111"><doi origin="wiley">10.1111/dme.2013.30.issue-11</doi><copyright ownership="thirdParty">Diabetic Medicine © 2013 Diabetes UK</copyright><numberingGroup><numbering type="journalVolume" number="30">30</numbering><numbering type="journalIssue">11</numbering></numberingGroup><coverDate startDate="2013-11">November 2013</coverDate></publicationMeta><publicationMeta level="unit" position="50" status="forIssue" type="shortCommunication" accessType="open"><doi>10.1111/dme.12303</doi><idGroup><id type="unit" value="DME12303"></id></idGroup><countGroup><count number="7" type="pageTotal"></count></countGroup><titleGroup><title type="articleCategory">Short Report: Treatment</title><title type="tocHeading1">Research Articles</title><title type="tocHeading2">Treatment</title></titleGroup><copyright ownership="publisher">© 2013 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.</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="2013-08-12" type="manuscriptAccepted"></event><event agent="SPS" date="2013-08-17" type="xmlCreated"></event><event agent="SPS" date="2013-09-25" type="xmlCorrected"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.2.5 mode:FullText" date="2013-10-17"></event><event type="publishedOnlineAccepted" date="2013-08-19"></event><event type="publishedOnlineEarlyUnpaginated" date="2013-09-30"></event><event type="firstOnline" date="2013-09-30"></event><event type="publishedOnlineFinalForm" date="2013-10-17"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-02"></event></eventGroup><numberingGroup><numbering type="pageFirst">1298</numbering><numbering type="pageLast">1304</numbering></numberingGroup><correspondenceTo><i>Correspondence to</i>: Helena W. Rodbard. E‐mail: <email>hrodbard@comcast.net</email></correspondenceTo><selfCitationGroup><citation type="self" xml:id="dme12303-cit-1001"><journalTitle>Diabet. Med.</journalTitle> <vol>30</vol>, <pageFirst>1298</pageFirst>–1304 (<pubYear year="2013">2013</pubYear>)</citation></selfCitationGroup><linkGroup><link type="toTypesetVersion" href="file:DME.DME12303.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial</title><title type="shortAuthors"><i>H. W. Rodbard et al</i>.</title></titleGroup><creators><creator affiliationRef="#dme12303-aff-0001" corresponding="yes" creatorRole="author" xml:id="dme12303-cr-0001"><personName><givenNames>H. W.</givenNames> <familyName>Rodbard</familyName></personName></creator><creator affiliationRef="#dme12303-aff-0002" creatorRole="author" xml:id="dme12303-cr-0002"><personName><givenNames>B.</givenNames> <familyName>Cariou</familyName></personName></creator><creator affiliationRef="#dme12303-aff-0003" creatorRole="author" xml:id="dme12303-cr-0003"><personName><givenNames>B.</givenNames> <familyName>Zinman</familyName></personName></creator><creator affiliationRef="#dme12303-aff-0004" creatorRole="author" xml:id="dme12303-cr-0004"><personName><givenNames>Y.</givenNames> <familyName>Handelsman</familyName></personName></creator><creator affiliationRef="#dme12303-aff-0005" creatorRole="author" xml:id="dme12303-cr-0005"><personName><givenNames>A.</givenNames> <familyName>Philis‐Tsimikas</familyName></personName></creator><creator affiliationRef="#dme12303-aff-0006" creatorRole="author" xml:id="dme12303-cr-0006"><personName><givenNames>T. V.</givenNames> <familyName>Skjøth</familyName></personName></creator><creator affiliationRef="#dme12303-aff-0006" creatorRole="author" xml:id="dme12303-cr-0007"><personName><givenNames>A.</givenNames> <familyName>Rana</familyName></personName></creator><creator affiliationRef="#dme12303-aff-0007" creatorRole="author" xml:id="dme12303-cr-0008"><personName><givenNames>C.</givenNames> <familyName>Mathieu</familyName></personName></creator> on behalf of <creator creatorRole="author" noteRef="#dme12303-note-0001" xml:id="dme12303-cr-0009"><groupName>The BEGIN Once Long Trial Investigators</groupName></creator></creators><affiliationGroup><affiliation countryCode="US" type="organization" xml:id="dme12303-aff-0001"><orgName>Endocrine and Metabolic Consultants</orgName> <address><city>Rockville</city> <countryPart>MD</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="FR" type="organization" xml:id="dme12303-aff-0002"><orgName>Clinique d'Endocrinologie</orgName> <orgName>l'Institut du Thorax</orgName> <address><city>CHU Nantes</city> <countryPart>Nantes</countryPart> <country>France</country></address></affiliation><affiliation countryCode="CA" type="organization" xml:id="dme12303-aff-0003"><orgName>Samuel Lunenfeld Research Institute</orgName> <orgName>Mount Sinai Hospital</orgName> <orgName>University of Toronto</orgName> <address><city>Toronto</city> <countryPart>ON</countryPart> <country>Canada</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="dme12303-aff-0004"><orgName>Metabolic Institute of America</orgName> <address><city>Tarzana</city> <countryPart>CA</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="dme12303-aff-0005"><orgName>Scripps Whittier Diabetes Institute</orgName> <address><city>La Jolla</city> <countryPart>CA</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="DK" type="organization" xml:id="dme12303-aff-0006"><orgName>Novo Nordisk A/S</orgName> <address><city>Søborg</city> <country>Denmark</country></address></affiliation><affiliation countryCode="BE" type="organization" xml:id="dme12303-aff-0007"><orgName>UZ Leuven</orgName> <orgName>University of Leuven</orgName> <address><city>Leuven</city> <country>Belgium</country></address></affiliation></affiliationGroup><fundingInfo><fundingAgency>Novo Nordisk</fundingAgency></fundingInfo><supportingInformation><supportingInfoItem><mediaResource alt="supporting" mimeType="application/msword" href="urn-x:wiley:07423071:media:dme12303:dme12303-sup-0001-OnlineAppendixTableS1-S2_AppendixS1"></mediaResource><caption><p><b>Table S1.</b> Participants meeting withdrawal criteria in extension study.</p><p><b>Table S2.</b> Demographic and baseline characteristics.</p><p><b>Appendix S1.</b> List of investigators in the BEGIN™ Once Long study.</p></caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:id="dme12303-abs-0001"><title type="main">Abstract</title><section xml:id="dme12303-sec-0001"><title type="main">Aims</title><p>The aim of this study was to compare long‐term safety and efficacy of the basal insulin analogue degludec with glargine in insulin‐naive subjects with Type 2 diabetes.</p></section><section xml:id="dme12303-sec-0002"><title type="main">Methods</title><p>This open‐label trial included a 52‐week core period followed by a 52‐week extension. Participants were randomized 3:1 to once‐daily degludec or glargine, administered with metformin ± dipeptidyl peptidase‐4 inhibitors. Basal insulin was titrated to target pre‐breakfast plasma glucose 3.9–4.9 mmol/l.</p></section><section xml:id="dme12303-sec-0003"><title type="main">Results</title><p>At end of treatment (104 weeks), mean HbA<sub>1c</sub> reductions were similar for degludec and glargine; estimated treatment difference between degludec and glargine was 1 mmol/mol (95% <fc>CI</fc> −1 to 3) [0.07% (95% <fc>CI</fc> −0.07 to 0.22)], <i>P </i>= 0.339 in the extension trial set (degludec 551, glargine 174), comprising subjects who completed core trial and continued into the extension trial. Overall confirmed hypoglycaemia rates (1.72 vs. 2.05 episodes/patient‐year), rates of adverse events possibly or probably related to trial product (0.19 events/patient‐year), weight gain (2.7 vs. 2.4 kg) and mean daily insulin doses (0.63 U/kg) were similar between treatments in the safety analysis set (degludec 766, glargine 257) comprising all treated subjects. Rates of nocturnal confirmed hypoglycaemia (0.27 vs. 0.46 episodes/patient‐year; <i>P </i>= 0.002) and severe hypoglycaemia (0.006 vs. 0.021 episodes/patient‐year, <i>P </i>= 0.023) were significantly lower with degludec for the safety analysis set (analysis based on intention‐to‐treat full analysis set comprising all randomized subjects).</p></section><section xml:id="dme12303-sec-0004"><title type="main">Conclusions</title><p>In Type 2 diabetes, insulin degludec in combination with oral anti‐diabetic drugs, safely and effectively improves long‐term glycaemic control, with a significantly lower risk of nocturnal hypoglycaemia as compared with glargine.</p></section></abstract><abstract type="short" xml:id="dme12303-abs-0002"><title type="main">What's new?</title><p><list style="bulleted" xml:id="dme12303-list-0001"><listItem>Insulin degludec, a basal insulin analogue, uses a novel protraction mechanism, resulting in a flat, stable profile and a duration of action greater than 42 h.</listItem><listItem>Consistent with its pharmacokinetic and pharmacodynamic profile, insulin degludec in combination with oral anti‐diabetic drugs provided long‐term glycaemic control similar to insulin glargine with a lower risk for nocturnal hypoglycaemia in insulin‐naive patients with Type 2 diabetes, in a 1‐year, randomized study.</listItem><listItem>This extension study reports 2‐year data, confirming that insulin degludec in combination with oral anti‐diabetic drugs maintains stable glycaemic control with a sustained benefit in reducing hypoglycaemic risk in Type 2 diabetes.</listItem></list></p></abstract></abstractGroup></contentMeta><noteGroup xml:id="dme12303-ntgp-0001"><note xml:id="dme12303-note-0001"><p>A complete list of the study investigators can be found in the Supporting Information.</p></note><note numbered="no" xml:id="dme12303-note-0002"><p>(Clinical Trials Registry No; NCT01193309)</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial</title></titleInfo><name type="personal"><namePart type="given">H. W.</namePart><namePart type="family">Rodbard</namePart><affiliation>Endocrine and Metabolic Consultants, MD, Rockville, USA</affiliation><description>: Helena W. Rodbard. E‐mail: </description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Cariou</namePart><affiliation>Clinique d'Endocrinologie, l'Institut du Thorax, Nantes, CHU Nantes, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Zinman</namePart><affiliation>Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, ON, Toronto, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Y.</namePart><namePart type="family">Handelsman</namePart><affiliation>Metabolic Institute of America, CA, Tarzana, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Philis‐Tsimikas</namePart><affiliation>Scripps Whittier Diabetes Institute, CA, La Jolla, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T. V.</namePart><namePart type="family">Skjøth</namePart><affiliation>Novo Nordisk A/S, Søborg, Denmark</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Rana</namePart><affiliation>Novo Nordisk A/S, Søborg, Denmark</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Mathieu</namePart><affiliation>UZ Leuven, University of Leuven, Leuven, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>The BEGIN Once Long Trial Investigators</namePart></name><typeOfResource>text</typeOfResource><genre type="brief-communication" displayLabel="shortCommunication"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><dateIssued encoding="w3cdtf">2013-11</dateIssued><dateCreated encoding="w3cdtf">2013-08-17</dateCreated><dateValid encoding="w3cdtf">2013-08-12</dateValid><edition>Diabet. Med. 30, 1298–1304 (2013)</edition><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>The aim of this study was to compare long‐term safety and efficacy of the basal insulin analogue degludec with glargine in insulin‐naive subjects with Type 2 diabetes.</abstract><abstract>This open‐label trial included a 52‐week core period followed by a 52‐week extension. Participants were randomized 3:1 to once‐daily degludec or glargine, administered with metformin ± dipeptidyl peptidase‐4 inhibitors. Basal insulin was titrated to target pre‐breakfast plasma glucose 3.9–4.9 mmol/l.</abstract><abstract>At end of treatment (104 weeks), mean HbA1c reductions were similar for degludec and glargine; estimated treatment difference between degludec and glargine was 1 mmol/mol (95% CI −1 to 3) [0.07% (95% CI −0.07 to 0.22)], P = 0.339 in the extension trial set (degludec 551, glargine 174), comprising subjects who completed core trial and continued into the extension trial. Overall confirmed hypoglycaemia rates (1.72 vs. 2.05 episodes/patient‐year), rates of adverse events possibly or probably related to trial product (0.19 events/patient‐year), weight gain (2.7 vs. 2.4 kg) and mean daily insulin doses (0.63 U/kg) were similar between treatments in the safety analysis set (degludec 766, glargine 257) comprising all treated subjects. Rates of nocturnal confirmed hypoglycaemia (0.27 vs. 0.46 episodes/patient‐year; P = 0.002) and severe hypoglycaemia (0.006 vs. 0.021 episodes/patient‐year, P = 0.023) were significantly lower with degludec for the safety analysis set (analysis based on intention‐to‐treat full analysis set comprising all randomized subjects).</abstract><abstract>In Type 2 diabetes, insulin degludec in combination with oral anti‐diabetic drugs, safely and effectively improves long‐term glycaemic control, with a significantly lower risk of nocturnal hypoglycaemia as compared with glargine.</abstract><abstract type="short">Insulin degludec, a basal insulin analogue, uses a novel protraction mechanism, resulting in a flat, stable profile and a duration of action greater than 42 h. Consistent with its pharmacokinetic and pharmacodynamic profile, insulin degludec in combination with oral anti‐diabetic drugs provided long‐term glycaemic control similar to insulin glargine with a lower risk for nocturnal hypoglycaemia in insulin‐naive patients with Type 2 diabetes, in a 1‐year, randomized study. This extension study reports 2‐year data, confirming that insulin degludec in combination with oral anti‐diabetic drugs maintains stable glycaemic control with a sustained benefit in reducing hypoglycaemic risk in Type 2 diabetes.</abstract><note type="additional physical form">Table S1. Participants meeting withdrawal criteria in extension study. Table S2. Demographic and baseline characteristics. Appendix S1. List of investigators in the BEGIN™ Once Long study.</note><note type="funding">Novo Nordisk</note><relatedItem type="host"><titleInfo><title>Diabetic Medicine</title></titleInfo><titleInfo type="abbreviated"><title>Diabet. Med.</title></titleInfo><genre type="journal">journal</genre><subject><genre>article-category</genre><topic>Short Report: Treatment</topic></subject><identifier type="ISSN">0742-3071</identifier><identifier type="eISSN">1464-5491</identifier><identifier type="DOI">10.1111/(ISSN)1464-5491</identifier><identifier type="PublisherID">DME</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>30</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>1298</start><end>1304</end><total>7</total></extent></part></relatedItem><identifier type="istex">A28BE9CAC594110081CCE842562F5BA985891B2C</identifier><identifier type="DOI">10.1111/dme.12303</identifier><identifier type="ArticleID">DME12303</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/A28BE9CAC594110081CCE842562F5BA985891B2C/enrichments/multicat</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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