Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU)
Identifieur interne : 000554 ( Ncbi/Merge ); précédent : 000553; suivant : 000555Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU)
Auteurs : M. Marre ; J. Shaw ; M. Br Ndle ; W M W. Bebakar ; N A Kamaruddin ; J. Strand ; M. Zdravkovic ; T D Le Thi ; S. ColagiuriSource :
- Diabetic Medicine [ 0742-3071 ] ; 2009.
Abstract
To compare the effects of combining liraglutide (0.6, 1.2 or 1.8 mg/day) or rosiglitazone 4 mg/day (all
In total, 1041 adults (mean ±
Liraglutide (1.2 or 1.8 mg) produced greater reductions in HbA1c from baseline, (−1.1%, baseline 8.5%) compared with placebo (+0.2%,
Liraglutide added to glimepiride was well tolerated and provided improved glycaemic control and favourable weight profile.
Url:
DOI: 10.1111/j.1464-5491.2009.02666.x
PubMed: 19317822
PubMed Central: 2871176
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU)</title><author><name sortKey="Marre, M" sort="Marre, M" uniqKey="Marre M" first="M" last="Marre">M. Marre</name></author><author><name sortKey="Shaw, J" sort="Shaw, J" uniqKey="Shaw J" first="J" last="Shaw">J. Shaw</name></author><author><name sortKey="Br Ndle, M" sort="Br Ndle, M" uniqKey="Br Ndle M" first="M" last="Br Ndle">M. Br Ndle</name></author><author><name sortKey="Bebakar, W M W" sort="Bebakar, W M W" uniqKey="Bebakar W" first="W M W" last="Bebakar">W M W. Bebakar</name></author><author><name sortKey="Kamaruddin, N A" sort="Kamaruddin, N A" uniqKey="Kamaruddin N" first="N A" last="Kamaruddin">N A Kamaruddin</name></author><author><name sortKey="Strand, J" sort="Strand, J" uniqKey="Strand J" first="J" last="Strand">J. Strand</name></author><author><name sortKey="Zdravkovic, M" sort="Zdravkovic, M" uniqKey="Zdravkovic M" first="M" last="Zdravkovic">M. Zdravkovic</name></author><author><name sortKey="Le Thi, T D" sort="Le Thi, T D" uniqKey="Le Thi T" first="T D" last="Le Thi">T D Le Thi</name></author><author><name sortKey="Colagiuri, S" sort="Colagiuri, S" uniqKey="Colagiuri S" first="S" last="Colagiuri">S. Colagiuri</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">19317822</idno><idno type="pmc">2871176</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2871176</idno><idno type="RBID">PMC:2871176</idno><idno type="doi">10.1111/j.1464-5491.2009.02666.x</idno><date when="2009">2009</date><idno type="wicri:Area/Pmc/Corpus">002402</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002402</idno><idno type="wicri:Area/Pmc/Curation">002252</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002252</idno><idno type="wicri:Area/Pmc/Checkpoint">002773</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">002773</idno><idno type="wicri:Area/Ncbi/Merge">000554</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU)</title><author><name sortKey="Marre, M" sort="Marre, M" uniqKey="Marre M" first="M" last="Marre">M. Marre</name></author><author><name sortKey="Shaw, J" sort="Shaw, J" uniqKey="Shaw J" first="J" last="Shaw">J. Shaw</name></author><author><name sortKey="Br Ndle, M" sort="Br Ndle, M" uniqKey="Br Ndle M" first="M" last="Br Ndle">M. Br Ndle</name></author><author><name sortKey="Bebakar, W M W" sort="Bebakar, W M W" uniqKey="Bebakar W" first="W M W" last="Bebakar">W M W. Bebakar</name></author><author><name sortKey="Kamaruddin, N A" sort="Kamaruddin, N A" uniqKey="Kamaruddin N" first="N A" last="Kamaruddin">N A Kamaruddin</name></author><author><name sortKey="Strand, J" sort="Strand, J" uniqKey="Strand J" first="J" last="Strand">J. Strand</name></author><author><name sortKey="Zdravkovic, M" sort="Zdravkovic, M" uniqKey="Zdravkovic M" first="M" last="Zdravkovic">M. Zdravkovic</name></author><author><name sortKey="Le Thi, T D" sort="Le Thi, T D" uniqKey="Le Thi T" first="T D" last="Le Thi">T D Le Thi</name></author><author><name sortKey="Colagiuri, S" sort="Colagiuri, S" uniqKey="Colagiuri S" first="S" last="Colagiuri">S. Colagiuri</name></author></analytic><series><title level="j">Diabetic Medicine</title><idno type="ISSN">0742-3071</idno><idno type="eISSN">1464-5491</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Aim</title><p>To compare the effects of combining liraglutide (0.6, 1.2 or 1.8 mg/day) or rosiglitazone 4 mg/day (all <italic>n</italic> ≥ 228) or placebo (<italic>n</italic> = 114) with glimepiride (2–4 mg/day) on glycaemic control, body weight and safety in Type 2 diabetes.</p></sec><sec><title>Methods</title><p>In total, 1041 adults (mean ± <sc>sd</sc>), age 56 ± 10 years, weight 82 ± 17 kg and glycated haemoglobin (HbA<sub>1c</sub>) 8.4 ± 1.0% at 116 sites in 21 countries were stratified based on previous oral glucose-lowering mono : combination therapies (30 : 70%) to participate in a five-arm, 26-week, double-dummy, randomized study.</p></sec><sec><title>Results</title><p>Liraglutide (1.2 or 1.8 mg) produced greater reductions in HbA<sub>1c</sub> from baseline, (−1.1%, baseline 8.5%) compared with placebo (+0.2%, <italic>P</italic> < 0.0001, baseline 8.4%) or rosiglitazone (−0.4%, <italic>P</italic> < 0.0001, baseline 8.4%) when added to glimepiride. Liraglutide 0.6 mg was less effective (−0.6%, baseline 8.4%). Fasting plasma glucose decreased by week 2, with a 1.6 mmol/l decrease from baseline at week 26 with liraglutide 1.2 mg (baseline 9.8 mmol/l) or 1.8 mg (baseline 9.7 mmol/l) compared with a 0.9 mmol/l increase (placebo, <italic>P</italic> < 0.0001, baseline 9.5 mmol/l) or 1.0 mmol/l decrease (rosiglitazone, <italic>P</italic> < 0.006, baseline 9.9 mmol/l). Decreases in postprandial plasma glucose from baseline were greater with liraglutide 1.2 or 1.8 mg [−2.5 to −2.7 mmol/l (baseline 12.9 mmol/l for both)] compared with placebo (−0.4 mmol/l, <italic>P</italic> < 0.0001, baseline 12.7 mmol/l) or rosiglitazone (−1.8 mmol/l, <italic>P</italic> < 0.05, baseline 13.0 mmol/l). Changes in body weight with liraglutide 1.8 mg (−0.2 kg, baseline 83.0 kg), 1.2 mg (+0.3 kg, baseline 80.0 kg) or placebo (−0.1 kg, baseline 81.9 kg) were less than with rosiglitazone (+2.1 kg, <italic>P</italic> < 0.0001, baseline 80.6 kg). Main adverse events for all treatments were minor hypoglycaemia (< 10%), nausea (< 11%), vomiting (< 5%) and diarrhoea (< 8%).</p></sec><sec><title>Conclusions</title><p>Liraglutide added to glimepiride was well tolerated and provided improved glycaemic control and favourable weight profile.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Holst, Jj" uniqKey="Holst J">JJ Holst</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nathan, Dm" uniqKey="Nathan D">DM Nathan</name></author><author><name sortKey="Buse, Jb" uniqKey="Buse J">JB Buse</name></author><author><name sortKey="Davidson, Mb" uniqKey="Davidson M">MB Davidson</name></author><author><name sortKey="Heine, Rj" uniqKey="Heine R">RJ Heine</name></author><author><name sortKey="Holman, Rr" uniqKey="Holman R">RR Holman</name></author><author><name sortKey="Sherwin, R" uniqKey="Sherwin R">R 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Diabet Med</journal-id><journal-id journal-id-type="publisher-id">dme</journal-id><journal-title-group><journal-title>Diabetic Medicine</journal-title></journal-title-group><issn pub-type="ppub">0742-3071</issn><issn pub-type="epub">1464-5491</issn><publisher><publisher-name>Blackwell Publishing Ltd</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">19317822</article-id><article-id pub-id-type="pmc">2871176</article-id><article-id pub-id-type="doi">10.1111/j.1464-5491.2009.02666.x</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Articles</subject><subj-group><subject>Treatment</subject></subj-group></subj-group></article-categories><title-group><article-title>Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU)</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Marre</surname><given-names>M</given-names></name></contrib><contrib contrib-type="author"><name><surname>Shaw</surname><given-names>J</given-names></name><xref ref-type="aff" rid="au1">*</xref></contrib><contrib contrib-type="author"><name><surname>Brändle</surname><given-names>M</given-names></name><xref ref-type="aff" rid="au2">†</xref></contrib><contrib contrib-type="author"><name><surname>Bebakar</surname><given-names>W M W</given-names></name><xref ref-type="aff" rid="au3">‡</xref></contrib><contrib contrib-type="author"><name><surname>Kamaruddin</surname><given-names>N A</given-names></name><xref ref-type="aff" rid="au4">§</xref></contrib><contrib contrib-type="author"><name><surname>Strand</surname><given-names>J</given-names></name><xref ref-type="aff" rid="au5">¶</xref></contrib><contrib contrib-type="author"><name><surname>Zdravkovic</surname><given-names>M</given-names></name><xref ref-type="aff" rid="au6">**</xref></contrib><contrib contrib-type="author"><name><surname>Le Thi</surname><given-names>T D</given-names></name><xref ref-type="aff" rid="au6">**</xref></contrib><contrib contrib-type="author"><name><surname>Colagiuri</surname><given-names>S</given-names></name><xref ref-type="aff" rid="au7">††</xref></contrib><on-behalf-of>on behalf of the LEAD-1 SU study group</on-behalf-of><aff><institution>Service d’Endocrinologie Diabétologie Nutrition, Groupe Hospitalier Bichat—Claude Bernard</institution><addr-line>Paris, France</addr-line></aff><aff id="au1"><label>*</label><institution>International Diabetes Institute</institution><addr-line>Melbourne, Australia</addr-line></aff><aff id="au2"><label>†</label><institution>Division of Endocrinology, Diabetes and Osteology</institution><addr-line>Kantonsspital St Gallen, Switzerland</addr-line></aff><aff id="au3"><label>‡</label><institution>Department of Medicine, Hospital Universiti Sains</institution><addr-line>Malaysia, Kelantan</addr-line></aff><aff id="au4"><label>§</label><institution>Department of Medicine, National University of Malaysia (UKM)</institution><addr-line>Kuala Lumpur, Malaysia</addr-line></aff><aff id="au5"><label>¶</label><institution>Oulun Diakonissalaitos</institution><addr-line>Oulu, Finland</addr-line></aff><aff id="au6"><label>**</label><institution>Novo Nordisk A/S</institution><addr-line>Bagsvaerd, Denmark</addr-line></aff><aff id="au7"><label>††</label><institution>Institute of Obesity, Nutrition and Exercise, University of Sydney</institution><addr-line>Australia</addr-line></aff></contrib-group><author-notes><corresp id="cor1"><italic>Correspondence to</italic>: Professor Michel Marre, Service d’Endocrinologie Diabétologie Nutrition, Groupe Hospitalier Bichat<italic>—</italic>Claude Bernard, 46 rue Henri Huchard, 75722 Paris Cedex 18, France. E-mail: <email>michel.marre@bch.ap-hop-paris.fr</email></corresp><fn><p>Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.</p></fn></author-notes><pub-date pub-type="ppub"><month>3</month><year>2009</year></pub-date><volume>26</volume><issue>3</issue><fpage>268</fpage><lpage>278</lpage><history><date date-type="accepted"><day>20</day><month>12</month><year>2008</year></date></history><permissions><copyright-statement>Journal compilation © 2009 Diabetes UK</copyright-statement><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.5/"><license-p>Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.</license-p></license></permissions><abstract><sec><title>Aim</title><p>To compare the effects of combining liraglutide (0.6, 1.2 or 1.8 mg/day) or rosiglitazone 4 mg/day (all <italic>n</italic> ≥ 228) or placebo (<italic>n</italic> = 114) with glimepiride (2–4 mg/day) on glycaemic control, body weight and safety in Type 2 diabetes.</p></sec><sec><title>Methods</title><p>In total, 1041 adults (mean ± <sc>sd</sc>), age 56 ± 10 years, weight 82 ± 17 kg and glycated haemoglobin (HbA<sub>1c</sub>) 8.4 ± 1.0% at 116 sites in 21 countries were stratified based on previous oral glucose-lowering mono : combination therapies (30 : 70%) to participate in a five-arm, 26-week, double-dummy, randomized study.</p></sec><sec><title>Results</title><p>Liraglutide (1.2 or 1.8 mg) produced greater reductions in HbA<sub>1c</sub> from baseline, (−1.1%, baseline 8.5%) compared with placebo (+0.2%, <italic>P</italic> < 0.0001, baseline 8.4%) or rosiglitazone (−0.4%, <italic>P</italic> < 0.0001, baseline 8.4%) when added to glimepiride. Liraglutide 0.6 mg was less effective (−0.6%, baseline 8.4%). Fasting plasma glucose decreased by week 2, with a 1.6 mmol/l decrease from baseline at week 26 with liraglutide 1.2 mg (baseline 9.8 mmol/l) or 1.8 mg (baseline 9.7 mmol/l) compared with a 0.9 mmol/l increase (placebo, <italic>P</italic> < 0.0001, baseline 9.5 mmol/l) or 1.0 mmol/l decrease (rosiglitazone, <italic>P</italic> < 0.006, baseline 9.9 mmol/l). Decreases in postprandial plasma glucose from baseline were greater with liraglutide 1.2 or 1.8 mg [−2.5 to −2.7 mmol/l (baseline 12.9 mmol/l for both)] compared with placebo (−0.4 mmol/l, <italic>P</italic> < 0.0001, baseline 12.7 mmol/l) or rosiglitazone (−1.8 mmol/l, <italic>P</italic> < 0.05, baseline 13.0 mmol/l). Changes in body weight with liraglutide 1.8 mg (−0.2 kg, baseline 83.0 kg), 1.2 mg (+0.3 kg, baseline 80.0 kg) or placebo (−0.1 kg, baseline 81.9 kg) were less than with rosiglitazone (+2.1 kg, <italic>P</italic> < 0.0001, baseline 80.6 kg). Main adverse events for all treatments were minor hypoglycaemia (< 10%), nausea (< 11%), vomiting (< 5%) and diarrhoea (< 8%).</p></sec><sec><title>Conclusions</title><p>Liraglutide added to glimepiride was well tolerated and provided improved glycaemic control and favourable weight profile.</p></sec></abstract><kwd-group><kwd>dipeptidyl peptidase-4</kwd><kwd>glucagon-like peptide-1 receptor agonist</kwd><kwd>incretin</kwd><kwd>insulinotropic</kwd><kwd>thiazolidinedione</kwd></kwd-group></article-meta></front></pmc><affiliations><list></list><tree><noCountry><name sortKey="Bebakar, W M W" sort="Bebakar, W M W" uniqKey="Bebakar W" first="W M W" last="Bebakar">W M W. Bebakar</name><name sortKey="Br Ndle, M" sort="Br Ndle, M" uniqKey="Br Ndle M" first="M" last="Br Ndle">M. Br Ndle</name><name sortKey="Colagiuri, S" sort="Colagiuri, S" uniqKey="Colagiuri S" first="S" last="Colagiuri">S. Colagiuri</name><name sortKey="Kamaruddin, N A" sort="Kamaruddin, N A" uniqKey="Kamaruddin N" first="N A" last="Kamaruddin">N A Kamaruddin</name><name sortKey="Le Thi, T D" sort="Le Thi, T D" uniqKey="Le Thi T" first="T D" last="Le Thi">T D Le Thi</name><name sortKey="Marre, M" sort="Marre, M" uniqKey="Marre M" first="M" last="Marre">M. Marre</name><name sortKey="Shaw, J" sort="Shaw, J" uniqKey="Shaw J" first="J" last="Shaw">J. Shaw</name><name sortKey="Strand, J" sort="Strand, J" uniqKey="Strand J" first="J" last="Strand">J. Strand</name><name sortKey="Zdravkovic, M" sort="Zdravkovic, M" uniqKey="Zdravkovic M" first="M" last="Zdravkovic">M. Zdravkovic</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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