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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 : 002E90 ( PascalFrancis/Corpus ); précédent : 002E89; suivant : 002E91

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)

Auteurs : M. Marre ; J. Shaw ; M. Br Ndle ; W. M. W. Bebakar ; N. A. Kamaruddin ; J. Strand ; M. Zdravkovic ; T. D. Le Thi ; S. Colagiuri

Source :

RBID : Pascal:09-0162156

Descripteurs français

English descriptors

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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Pour connaître la documentation sur le format Inist Standard.

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A03   1    @0 Diabetic med.
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A06       @2 3
A08 01  1  ENG  @1 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)
A11 01  1    @1 MARRE (M.)
A11 02  1    @1 SHAW (J.)
A11 03  1    @1 BRÄNDLE (M.)
A11 04  1    @1 BEBAKAR (W. M. W.)
A11 05  1    @1 KAMARUDDIN (N. A.)
A11 06  1    @1 STRAND (J.)
A11 07  1    @1 ZDRAVKOVIC (M.)
A11 08  1    @1 LE THI (T. D.)
A11 09  1    @1 COLAGIURI (S.)
A14 01      @1 Service d'Endocrinologie Diabétologie Nutrition, Groupe Hospitalier Bichat-Claude Bernard @2 Paris @3 FRA @Z 1 aut.
A14 02      @1 International Diabetes Institute @2 Melbourne @3 AUS @Z 2 aut.
A14 03      @1 Division of Endocrinology, Diabetes and Osteology, Kantonsspital St Gallen @3 CHE @Z 3 aut.
A14 04      @1 Department of Medicine, Hospital Universiti Sains @2 Kelantan @3 MYS @Z 4 aut.
A14 05      @1 Departmentof Medicine, National University of Malaysia (UKM) @2 Kuala Lumpur @3 MYS @Z 5 aut.
A14 06      @1 Oulun Diakonissalaitos @2 Oulu @3 FIN @Z 6 aut.
A14 07      @1 NovoNordisk A/S @2 Bagsvaerd @3 DNK @Z 7 aut. @Z 8 aut.
A14 08      @1 Insitute of Obesity, Nutrition and Exercise, University of Sydney @3 AUS @Z 9 aut.
A17 01  1    @1 LEAD-1 SU study group @3 INC
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A21       @1 2009
A23 01      @0 ENG
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A60       @1 P
A61       @0 A
A64 01  1    @0 Diabetic medicine
A66 01      @0 GBR
C01 01    ENG  @0 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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C07 06  X  ENG  @0 Heavy metal @5 40
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N21       @1 117

Format Inist (serveur)

NO : PASCAL 09-0162156 INIST
ET : 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)
AU : MARRE (M.); SHAW (J.); BRÄNDLE (M.); BEBAKAR (W. M. W.); KAMARUDDIN (N. A.); STRAND (J.); ZDRAVKOVIC (M.); LE THI (T. D.); COLAGIURI (S.)
AF : Service d'Endocrinologie Diabétologie Nutrition, Groupe Hospitalier Bichat-Claude Bernard/Paris/France (1 aut.); International Diabetes Institute/Melbourne/Australie (2 aut.); Division of Endocrinology, Diabetes and Osteology, Kantonsspital St Gallen/Suisse (3 aut.); Department of Medicine, Hospital Universiti Sains/Kelantan/Malaisie (4 aut.); Departmentof Medicine, National University of Malaysia (UKM)/Kuala Lumpur/Malaisie (5 aut.); Oulun Diakonissalaitos/Oulu/Finlande (6 aut.); NovoNordisk A/S/Bagsvaerd/Danemark (7 aut., 8 aut.); Insitute of Obesity, Nutrition and Exercise, University of Sydney/Australie (9 aut.)
DT : Publication en série; Niveau analytique
SO : Diabetic medicine; ISSN 0742-3071; Coden DIMEEV; Royaume-Uni; Da. 2009; Vol. 26; No. 3; Pp. 268-278; Bibl. 22 ref.
LA : Anglais
EA : 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.
CC : 002A16E; 002A28; 002B21E01A
FD : 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
FG : Hydrolases; Enzyme; Hormone gastrointestinale; Biométrie corporelle; Endocrinopathie; Métal lourd; Trouble de la nutrition
ED : Liraglutide; Daily dose; Human; Rosiglitazone; Glucagon like peptide 1; Analog; Type 2 diabetes; Improvement; Glycemia; Body weight; Surveillance; Comparative study; Placebo; Lead; Peptidases; Agonist; Thiazolidinedione derivatives; Endocrinology; Metabolic diseases; Hypoglycemic agent; Nutritional status; Incretin
EG : Hydrolases; Enzyme; Gastrointestinal hormone; Corporal biometry; Endocrinopathy; Heavy metal; Nutrition disorder
SD : Liraglutida; Dosis diaria; Hombre; Rosiglitazona; Péptido GLP1; Análogo; Diabetes de tipo 2; Mejora; Glucemia; Peso corporal; Vigilancia; Estudio comparativo; Placebo; Plomo; Peptidases; Agonista; Tiazolidinediona derivado; Endocrinología; Metabolismo patología; Hipoglicemiante; Estado nutricional; Incretina
LO : INIST-20274.354000187360670110
ID : 09-0162156

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Pascal:09-0162156

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<name sortKey="Br Ndle, M" sort="Br Ndle, M" uniqKey="Br Ndle M" first="M." last="Br Ndle">M. Br Ndle</name>
<affiliation>
<inist:fA14 i1="03">
<s1>Division of Endocrinology, Diabetes and Osteology, Kantonsspital St Gallen</s1>
<s3>CHE</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</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>
<affiliation>
<inist:fA14 i1="04">
<s1>Department of Medicine, Hospital Universiti Sains</s1>
<s2>Kelantan</s2>
<s3>MYS</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Kamaruddin, N A" sort="Kamaruddin, N A" uniqKey="Kamaruddin N" first="N. A." last="Kamaruddin">N. A. Kamaruddin</name>
<affiliation>
<inist:fA14 i1="05">
<s1>Departmentof Medicine, National University of Malaysia (UKM)</s1>
<s2>Kuala Lumpur</s2>
<s3>MYS</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Strand, J" sort="Strand, J" uniqKey="Strand J" first="J." last="Strand">J. Strand</name>
<affiliation>
<inist:fA14 i1="06">
<s1>Oulun Diakonissalaitos</s1>
<s2>Oulu</s2>
<s3>FIN</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Zdravkovic, M" sort="Zdravkovic, M" uniqKey="Zdravkovic M" first="M." last="Zdravkovic">M. Zdravkovic</name>
<affiliation>
<inist:fA14 i1="07">
<s1>NovoNordisk A/S</s1>
<s2>Bagsvaerd</s2>
<s3>DNK</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</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>
<affiliation>
<inist:fA14 i1="07">
<s1>NovoNordisk A/S</s1>
<s2>Bagsvaerd</s2>
<s3>DNK</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Colagiuri, S" sort="Colagiuri, S" uniqKey="Colagiuri S" first="S." last="Colagiuri">S. Colagiuri</name>
<affiliation>
<inist:fA14 i1="08">
<s1>Insitute of Obesity, Nutrition and Exercise, University of Sydney</s1>
<s3>AUS</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Diabetic medicine</title>
<title level="j" type="abbreviated">Diabetic med.</title>
<idno type="ISSN">0742-3071</idno>
<imprint>
<date when="2009">2009</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Diabetic medicine</title>
<title level="j" type="abbreviated">Diabetic med.</title>
<idno type="ISSN">0742-3071</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Agonist</term>
<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>
</keywords>
<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>
<term>Endocrinologie</term>
<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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<fA05>
<s2>26</s2>
</fA05>
<fA06>
<s2>3</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG">
<s1>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)</s1>
</fA08>
<fA11 i1="01" i2="1">
<s1>MARRE (M.)</s1>
</fA11>
<fA11 i1="02" i2="1">
<s1>SHAW (J.)</s1>
</fA11>
<fA11 i1="03" i2="1">
<s1>BRÄNDLE (M.)</s1>
</fA11>
<fA11 i1="04" i2="1">
<s1>BEBAKAR (W. M. W.)</s1>
</fA11>
<fA11 i1="05" i2="1">
<s1>KAMARUDDIN (N. A.)</s1>
</fA11>
<fA11 i1="06" i2="1">
<s1>STRAND (J.)</s1>
</fA11>
<fA11 i1="07" i2="1">
<s1>ZDRAVKOVIC (M.)</s1>
</fA11>
<fA11 i1="08" i2="1">
<s1>LE THI (T. D.)</s1>
</fA11>
<fA11 i1="09" i2="1">
<s1>COLAGIURI (S.)</s1>
</fA11>
<fA14 i1="01">
<s1>Service d'Endocrinologie Diabétologie Nutrition, Groupe Hospitalier Bichat-Claude Bernard</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02">
<s1>International Diabetes Institute</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03">
<s1>Division of Endocrinology, Diabetes and Osteology, Kantonsspital St Gallen</s1>
<s3>CHE</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04">
<s1>Department of Medicine, Hospital Universiti Sains</s1>
<s2>Kelantan</s2>
<s3>MYS</s3>
<sZ>4 aut.</sZ>
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<fA14 i1="05">
<s1>Departmentof Medicine, National University of Malaysia (UKM)</s1>
<s2>Kuala Lumpur</s2>
<s3>MYS</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06">
<s1>Oulun Diakonissalaitos</s1>
<s2>Oulu</s2>
<s3>FIN</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07">
<s1>NovoNordisk A/S</s1>
<s2>Bagsvaerd</s2>
<s3>DNK</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="08">
<s1>Insitute of Obesity, Nutrition and Exercise, University of Sydney</s1>
<s3>AUS</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1">
<s1>LEAD-1 SU study group</s1>
<s3>INC</s3>
</fA17>
<fA20>
<s1>268-278</s1>
</fA20>
<fA21>
<s1>2009</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>20274</s2>
<s5>354000187360670110</s5>
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<fA44>
<s0>0000</s0>
<s1>© 2009 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>22 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>09-0162156</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>Diabetic medicine</s0>
</fA64>
<fA66 i1="01">
<s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002A16E</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002A28</s0>
</fC02>
<fC02 i1="03" i2="X">
<s0>002B21E01A</s0>
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<s0>Liraglutide</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Liraglutide</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Liraglutida</s0>
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<s5>01</s5>
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<s0>Dose journalière</s0>
<s5>02</s5>
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<s5>02</s5>
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<s5>02</s5>
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<s5>03</s5>
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<s5>03</s5>
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<s5>03</s5>
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<s5>04</s5>
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<s0>Rosiglitazone</s0>
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<s2>FR</s2>
<s5>04</s5>
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<s0>Rosiglitazona</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
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<s0>Peptide GLP1</s0>
<s5>05</s5>
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<s0>Glucagon like peptide 1</s0>
<s5>05</s5>
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<s0>Péptido GLP1</s0>
<s5>05</s5>
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<s5>06</s5>
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<s0>Analog</s0>
<s5>06</s5>
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<s5>07</s5>
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<s0>Type 2 diabetes</s0>
<s2>NM</s2>
<s5>07</s5>
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<fC03 i1="07" i2="X" l="SPA">
<s0>Diabetes de tipo 2</s0>
<s2>NM</s2>
<s5>07</s5>
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<s5>08</s5>
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<s0>Improvement</s0>
<s5>08</s5>
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<s5>08</s5>
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<s2>NC</s2>
<s2>FX</s2>
<s5>19</s5>
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<s0>Plomo</s0>
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<s2>FX</s2>
<s5>19</s5>
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<s0>Peptidases</s0>
<s2>FE</s2>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG">
<s0>Peptidases</s0>
<s2>FE</s2>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA">
<s0>Peptidases</s0>
<s2>FE</s2>
<s5>20</s5>
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<s0>Agoniste</s0>
<s5>21</s5>
</fC03>
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<s0>Agonist</s0>
<s5>21</s5>
</fC03>
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<s0>Agonista</s0>
<s5>21</s5>
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<s0>Dérivé de la thiazolidinedione</s0>
<s5>22</s5>
</fC03>
<fC03 i1="17" i2="X" l="ENG">
<s0>Thiazolidinedione derivatives</s0>
<s5>22</s5>
</fC03>
<fC03 i1="17" i2="X" l="SPA">
<s0>Tiazolidinediona derivado</s0>
<s5>22</s5>
</fC03>
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<s0>Endocrinologie</s0>
<s5>23</s5>
</fC03>
<fC03 i1="18" i2="X" l="ENG">
<s0>Endocrinology</s0>
<s5>23</s5>
</fC03>
<fC03 i1="18" i2="X" l="SPA">
<s0>Endocrinología</s0>
<s5>23</s5>
</fC03>
<fC03 i1="19" i2="X" l="FRE">
<s0>Maladie métabolique</s0>
<s5>24</s5>
</fC03>
<fC03 i1="19" i2="X" l="ENG">
<s0>Metabolic diseases</s0>
<s5>24</s5>
</fC03>
<fC03 i1="19" i2="X" l="SPA">
<s0>Metabolismo patología</s0>
<s5>24</s5>
</fC03>
<fC03 i1="20" i2="X" l="FRE">
<s0>Hypoglycémiant</s0>
<s5>25</s5>
</fC03>
<fC03 i1="20" i2="X" l="ENG">
<s0>Hypoglycemic agent</s0>
<s5>25</s5>
</fC03>
<fC03 i1="20" i2="X" l="SPA">
<s0>Hipoglicemiante</s0>
<s5>25</s5>
</fC03>
<fC03 i1="21" i2="X" l="FRE">
<s0>Etat nutritionnel</s0>
<s5>26</s5>
</fC03>
<fC03 i1="21" i2="X" l="ENG">
<s0>Nutritional status</s0>
<s5>26</s5>
</fC03>
<fC03 i1="21" i2="X" l="SPA">
<s0>Estado nutricional</s0>
<s5>26</s5>
</fC03>
<fC03 i1="22" i2="X" l="FRE">
<s0>Récepteur GLP-1</s0>
<s4>INC</s4>
<s5>86</s5>
</fC03>
<fC03 i1="23" i2="X" l="FRE">
<s0>Incrétine</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC03 i1="23" i2="X" l="ENG">
<s0>Incretin</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC03 i1="23" i2="X" l="SPA">
<s0>Incretina</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Hormone gastrointestinale</s0>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Gastrointestinal hormone</s0>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Hormona gastrointestinal</s0>
<s5>37</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Biométrie corporelle</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Corporal biometry</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Biometría corporal</s0>
<s5>38</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Endocrinopathie</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Endocrinopathy</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Endocrinopatía</s0>
<s5>39</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Métal lourd</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Heavy metal</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Metal pesado</s0>
<s5>40</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE">
<s0>Trouble de la nutrition</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG">
<s0>Nutrition disorder</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA">
<s0>Trastorno nutricíon</s0>
<s5>41</s5>
</fC07>
<fN21>
<s1>117</s1>
</fN21>
</pA>
</standard>
<server>
<NO>PASCAL 09-0162156 INIST</NO>
<ET>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)</ET>
<AU>MARRE (M.); SHAW (J.); BRÄNDLE (M.); BEBAKAR (W. M. W.); KAMARUDDIN (N. A.); STRAND (J.); ZDRAVKOVIC (M.); LE THI (T. D.); COLAGIURI (S.)</AU>
<AF>Service d'Endocrinologie Diabétologie Nutrition, Groupe Hospitalier Bichat-Claude Bernard/Paris/France (1 aut.); International Diabetes Institute/Melbourne/Australie (2 aut.); Division of Endocrinology, Diabetes and Osteology, Kantonsspital St Gallen/Suisse (3 aut.); Department of Medicine, Hospital Universiti Sains/Kelantan/Malaisie (4 aut.); Departmentof Medicine, National University of Malaysia (UKM)/Kuala Lumpur/Malaisie (5 aut.); Oulun Diakonissalaitos/Oulu/Finlande (6 aut.); NovoNordisk A/S/Bagsvaerd/Danemark (7 aut., 8 aut.); Insitute of Obesity, Nutrition and Exercise, University of Sydney/Australie (9 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Diabetic medicine; ISSN 0742-3071; Coden DIMEEV; Royaume-Uni; Da. 2009; Vol. 26; No. 3; Pp. 268-278; Bibl. 22 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002A16E; 002A28; 002B21E01A</CC>
<FD>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</FD>
<FG>Hydrolases; Enzyme; Hormone gastrointestinale; Biométrie corporelle; Endocrinopathie; Métal lourd; Trouble de la nutrition</FG>
<ED>Liraglutide; Daily dose; Human; Rosiglitazone; Glucagon like peptide 1; Analog; Type 2 diabetes; Improvement; Glycemia; Body weight; Surveillance; Comparative study; Placebo; Lead; Peptidases; Agonist; Thiazolidinedione derivatives; Endocrinology; Metabolic diseases; Hypoglycemic agent; Nutritional status; Incretin</ED>
<EG>Hydrolases; Enzyme; Gastrointestinal hormone; Corporal biometry; Endocrinopathy; Heavy metal; Nutrition disorder</EG>
<SD>Liraglutida; Dosis diaria; Hombre; Rosiglitazona; Péptido GLP1; Análogo; Diabetes de tipo 2; Mejora; Glucemia; Peso corporal; Vigilancia; Estudio comparativo; Placebo; Plomo; Peptidases; Agonista; Tiazolidinediona derivado; Endocrinología; Metabolismo patología; Hipoglicemiante; Estado nutricional; Incretina</SD>
<LO>INIST-20274.354000187360670110</LO>
<ID>09-0162156</ID>
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