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/Curation ); 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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<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>
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<author><name sortKey="Br Ndle, M" sort="Br Ndle, M" uniqKey="Br Ndle M" first="M" last="Br Ndle">M. Br Ndle</name>
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<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>
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<author><name sortKey="Kamaruddin, N A" sort="Kamaruddin, N A" uniqKey="Kamaruddin N" first="N A" last="Kamaruddin">N A Kamaruddin</name>
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<author><name sortKey="Strand, J" sort="Strand, J" uniqKey="Strand J" first="J" last="Strand">J. Strand</name>
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<author><name sortKey="Zdravkovic, M" sort="Zdravkovic, M" uniqKey="Zdravkovic M" first="M" last="Zdravkovic">M. Zdravkovic</name>
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<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>
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<author><name sortKey="Colagiuri, S" sort="Colagiuri, S" uniqKey="Colagiuri S" first="S" last="Colagiuri">S. Colagiuri</name>
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<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>
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<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>
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