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 : 008996 ( Main/Merge ); précédent : 008995; suivant : 008997Liraglutide, 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 [France] ; J. Shaw [Australie] ; M. Br Ndle [Suisse] ; W. M. W. Bebakar [Malaisie] ; N. A. Kamaruddin [Malaisie] ; J. Strand [Finlande] ; M. Zdravkovic [Danemark] ; T. D. Le Thi [Danemark] ; S. Colagiuri [Australie]Source :
- Diabetic medicine [ 0742-3071 ] ; 2009.
Descripteurs français
- Pascal (Inist)
- Liraglutide, Dose journalière, Homme, Rosiglitazone, Peptide GLP1, Analogue, Diabète de type 2, Amélioration, Glycémie, Poids corporel, Surveillance, Etude comparative, Placebo, Plomb, Peptidases, Agoniste, Dérivé de la thiazolidinedione, Endocrinologie, Maladie métabolique, Hypoglycémiant, Etat nutritionnel, Récepteur GLP-1, Incrétine.
- Wicri :
English descriptors
- KwdEn :
- Agonist, Analog, Body weight, Comparative study, Daily dose, Endocrinology, Glucagon like peptide 1, Glycemia, Human, Hypoglycemic agent, Improvement, Incretin, Lead, Liraglutide, Metabolic diseases, Nutritional status, Peptidases, Placebo, Rosiglitazone, Surveillance, Thiazolidinedione derivatives, Type 2 diabetes.
Abstract
Aim To compare the effects of combining liraglutide (0.6, 1.2 or 1.8 mg/day) or rosiglitazone 4 mg/day (all n ≥228) or placebo (n = 114) with glimepiride (2-4 mg/day) on glycaemic control, body weight and safety in Type 2 diabetes. Methods In total, 1041 adults (mean ± so), age 56 ± 10 years, weight 82 ± 17 kg and glycated haemoglobin (HbA1c) 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. Results Liraglutide (1.2 or 1.8 mg) produced greater reductions in HbA1c from baseline, (-1.1%, baseline 8.5%) compared with placebo (+0.2%, P < 0.0001, baseline 8.4%) or rosiglitazone (-0.4%, P < 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, P < 0.0001, baseline 9.5 mmol/l) or 1.0 mmol/l decrease (rosiglitazone, P < 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, P< 0.0001, baseline 12.7 mmol/l) or rosiglitazone (-1.8 mmol/l, P < 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, P < 0.0001, baseline 80.6 kg). Main adverse events for all treatments were minor hypoglycaemia (< 10%), nausea (<11%), vomiting (< 5%) and diarrhoea (< 8%). Conclusions Liraglutide added to glimepiride was well tolerated and provided improved glycaemic control and favourable weight profile.
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<series><title level="j" type="main">Diabetic medicine</title>
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<term>Analog</term>
<term>Body weight</term>
<term>Comparative study</term>
<term>Daily dose</term>
<term>Endocrinology</term>
<term>Glucagon like peptide 1</term>
<term>Glycemia</term>
<term>Human</term>
<term>Hypoglycemic agent</term>
<term>Improvement</term>
<term>Incretin</term>
<term>Lead</term>
<term>Liraglutide</term>
<term>Metabolic diseases</term>
<term>Nutritional status</term>
<term>Peptidases</term>
<term>Placebo</term>
<term>Rosiglitazone</term>
<term>Surveillance</term>
<term>Thiazolidinedione derivatives</term>
<term>Type 2 diabetes</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Liraglutide</term>
<term>Dose journalière</term>
<term>Homme</term>
<term>Rosiglitazone</term>
<term>Peptide GLP1</term>
<term>Analogue</term>
<term>Diabète de type 2</term>
<term>Amélioration</term>
<term>Glycémie</term>
<term>Poids corporel</term>
<term>Surveillance</term>
<term>Etude comparative</term>
<term>Placebo</term>
<term>Plomb</term>
<term>Peptidases</term>
<term>Agoniste</term>
<term>Dérivé de la thiazolidinedione</term>
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<term>Maladie métabolique</term>
<term>Hypoglycémiant</term>
<term>Etat nutritionnel</term>
<term>Récepteur GLP-1</term>
<term>Incrétine</term>
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<front><div type="abstract" xml:lang="en">Aim To compare the effects of combining liraglutide (0.6, 1.2 or 1.8 mg/day) or rosiglitazone 4 mg/day (all n ≥228) or placebo (n = 114) with glimepiride (2-4 mg/day) on glycaemic control, body weight and safety in Type 2 diabetes. Methods In total, 1041 adults (mean ± so), 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. Results 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%, P < 0.0001, baseline 8.4%) or rosiglitazone (-0.4%, P < 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, P < 0.0001, baseline 9.5 mmol/l) or 1.0 mmol/l decrease (rosiglitazone, P < 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, P< 0.0001, baseline 12.7 mmol/l) or rosiglitazone (-1.8 mmol/l, P < 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, P < 0.0001, baseline 80.6 kg). Main adverse events for all treatments were minor hypoglycaemia (< 10%), nausea (<11%), vomiting (< 5%) and diarrhoea (< 8%). Conclusions Liraglutide added to glimepiride was well tolerated and provided improved glycaemic control and favourable weight profile.</div>
</front>
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<affiliations><list><country><li>Australie</li>
<li>Danemark</li>
<li>Finlande</li>
<li>France</li>
<li>Malaisie</li>
<li>Suisse</li>
</country>
<region><li>Nouvelle-Galles du Sud</li>
<li>Victoria (État)</li>
<li>Île-de-France</li>
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<settlement><li>Melbourne</li>
<li>Paris</li>
<li>Sydney</li>
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<orgName><li>Université de Sydney</li>
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<tree><country name="France"><region name="Île-de-France"><name sortKey="Marre, M" sort="Marre, M" uniqKey="Marre M" first="M." last="Marre">M. Marre</name>
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<country name="Australie"><region name="Victoria (État)"><name sortKey="Shaw, J" sort="Shaw, J" uniqKey="Shaw J" first="J." last="Shaw">J. Shaw</name>
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<name sortKey="Colagiuri, S" sort="Colagiuri, S" uniqKey="Colagiuri S" first="S." last="Colagiuri">S. Colagiuri</name>
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<country name="Malaisie"><noRegion><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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<country name="Finlande"><noRegion><name sortKey="Strand, J" sort="Strand, J" uniqKey="Strand J" first="J." last="Strand">J. Strand</name>
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<country name="Danemark"><noRegion><name sortKey="Zdravkovic, M" sort="Zdravkovic, M" uniqKey="Zdravkovic M" first="M." last="Zdravkovic">M. Zdravkovic</name>
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<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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