Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA-T2D™ trial.
Identifieur interne : 002F20 ( Main/Exploration ); précédent : 002F19; suivant : 002F21Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA-T2D™ trial.
Auteurs : Per-Henrik Groop [Finlande] ; Mark E. Cooper [Australie] ; Vlado Perkovic [Australie] ; Kumar Sharma [États-Unis] ; Guntram Schernthaner [Autriche] ; Masakazu Haneda [Japon] ; Berthold Hocher [Allemagne] ; Maud Gordat [France] ; Jessica Cescutti [France] ; Hans-Juergen Woerle [Allemagne] ; Maximilian Von Eynatten [Allemagne]Source :
- Diabetes & vascular disease research [ 1752-8984 ] ; 2015.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Albuminurie (diétothérapie), Albuminurie (sang), Diabète de type 2 (), Diabète de type 2 (traitement médicamenteux), Femelle, Glycémie (), Humains, Hyperglycémie (traitement médicamenteux), Hypoglycémiants (usage thérapeutique), Inhibiteurs de la dipeptidyl-peptidase IV (usage thérapeutique), Jeune adulte, Linagliptine (usage thérapeutique), Maladies du rein (), Maladies du rein (étiologie), Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus.
- MESH :
- diétothérapie : Albuminurie.
- sang : Albuminurie.
- traitement médicamenteux : Diabète de type 2, Hyperglycémie.
- usage thérapeutique : Hypoglycémiants, Inhibiteurs de la dipeptidyl-peptidase IV, Linagliptine.
- étiologie : Maladies du rein.
- Adolescent, Adulte, Adulte d'âge moyen, Diabète de type 2, Femelle, Glycémie, Humains, Jeune adulte, Maladies du rein, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Albuminuria (blood), Albuminuria (diet therapy), Blood Glucose (drug effects), Diabetes Mellitus, Type 2 (complications), Diabetes Mellitus, Type 2 (drug therapy), Dipeptidyl-Peptidase IV Inhibitors (therapeutic use), Double-Blind Method, Female, Humans, Hyperglycemia (drug therapy), Hypoglycemic Agents (therapeutic use), Kidney Diseases (complications), Kidney Diseases (etiology), Linagliptin (therapeutic use), Male, Middle Aged, Treatment Outcome, Young Adult.
- MESH :
- chemical , drug effects : Blood Glucose.
- blood : Albuminuria.
- complications : Diabetes Mellitus, Type 2, Kidney Diseases.
- diet therapy : Albuminuria.
- drug therapy : Diabetes Mellitus, Type 2, Hyperglycemia.
- etiology : Kidney Diseases.
- chemical , therapeutic use : Dipeptidyl-Peptidase IV Inhibitors, Hypoglycemic Agents, Linagliptin.
- Adolescent, Adult, Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome, Young Adult.
Abstract
Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects with Renal Disease with LINAgliptin (MARLINA-T2D™), a multicentre, multinational, randomized, double-blind, placebo-controlled, parallel-group, phase 3b clinical trial, aims to further define the potential renal effects of dipeptidyl peptidase-4 inhibition beyond glycaemic control. A total of 350 eligible individuals with inadequately controlled type 2 diabetes and evidence of renal disease are planned to be randomized in a 1:1 ratio to receive either linagliptin 5 mg or placebo in addition to their stable glucose-lowering background therapy for 24 weeks. Two predefined main endpoints will be tested in a hierarchical manner: (1) change from baseline in glycated haemoglobin and (2) time-weighted average of percentage change from baseline in urinary albumin-to-creatinine ratio. Both endpoints are sufficiently powered to test for superiority versus placebo after 24 weeks with α = 0.05. MARLINA-T2D™ is the first of its class to prospectively explore both the glucose- and albuminuria-lowering potential of a dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes and evidence of renal disease.
DOI: 10.1177/1479164115579002
PubMed: 26224765
Affiliations:
- Allemagne, Australie, Autriche, Finlande, France, Japon, États-Unis
- Brandebourg, Californie, Champagne-Ardenne, Grand Est, Nouvelle-Galles du Sud, Vienne (Autriche)
- Potsdam, Reims, Sydney, Vienne (Autriche)
- Université de Potsdam, Université de Sydney
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Le document en format XML
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hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA-T2D™ trial.</title><author><name sortKey="Groop, Per Henrik" sort="Groop, Per Henrik" uniqKey="Groop P" first="Per-Henrik" last="Groop">Per-Henrik Groop</name><affiliation wicri:level="1"><nlm:affiliation>Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland Baker IDI Heart & Diabetes Institute, Melbourne, VIC, Australia per-henrik.groop@helsinki.fi.</nlm:affiliation><country wicri:rule="url">Finlande</country><wicri:regionArea>Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland Baker IDI Heart & Diabetes Institute, Melbourne, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Cooper, Mark E" sort="Cooper, Mark E" uniqKey="Cooper M" first="Mark E" last="Cooper">Mark E. Cooper</name><affiliation wicri:level="1"><nlm:affiliation>Baker IDI Heart & Diabetes Institute, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Baker IDI Heart & Diabetes Institute, Melbourne, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Perkovic, Vlado" sort="Perkovic, Vlado" uniqKey="Perkovic V" first="Vlado" last="Perkovic">Vlado Perkovic</name><affiliation wicri:level="4"><nlm:affiliation>The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>The George Institute for Global Health, University of Sydney, Sydney, NSW</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Sharma, Kumar" sort="Sharma, Kumar" uniqKey="Sharma K" first="Kumar" last="Sharma">Kumar Sharma</name><affiliation wicri:level="2"><nlm:affiliation>Research Service and Division of Nephrology-Hypertension, Veterans Affairs San Diego Healthcare System, Veterans Medical Research Foundation, San Diego, CA, USA Center for Renal Translational Medicine, Department of Medicine, University of California, San Diego, La Jolla, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Research Service and Division of Nephrology-Hypertension, Veterans Affairs San Diego Healthcare System, Veterans Medical Research Foundation, San Diego, CA, USA Center for Renal Translational Medicine, Department of Medicine, University of California, San Diego, La Jolla, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Schernthaner, Guntram" sort="Schernthaner, Guntram" uniqKey="Schernthaner G" first="Guntram" last="Schernthaner">Guntram Schernthaner</name><affiliation wicri:level="3"><nlm:affiliation>Department of Internal Medicine, Rudolfstiftung Hospital, Vienna, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Internal Medicine, Rudolfstiftung Hospital, Vienna</wicri:regionArea><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Haneda, Masakazu" sort="Haneda, Masakazu" uniqKey="Haneda M" first="Masakazu" last="Haneda">Masakazu Haneda</name><affiliation wicri:level="1"><nlm:affiliation>Division of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>Division of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, Asahikawa</wicri:regionArea><wicri:noRegion>Asahikawa</wicri:noRegion></affiliation></author><author><name sortKey="Hocher, Berthold" sort="Hocher, Berthold" uniqKey="Hocher B" first="Berthold" last="Hocher">Berthold Hocher</name><affiliation wicri:level="4"><nlm:affiliation>Institute of Nutritional Science, University of Potsdam, Potsdam, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Nutritional Science, University of Potsdam, Potsdam</wicri:regionArea><placeName><region type="land" nuts="2">Brandebourg</region><settlement type="city">Potsdam</settlement><settlement type="city">Potsdam</settlement></placeName><orgName type="university">Université de Potsdam</orgName></affiliation></author><author><name sortKey="Gordat, Maud" sort="Gordat, Maud" uniqKey="Gordat M" first="Maud" last="Gordat">Maud Gordat</name><affiliation wicri:level="3"><nlm:affiliation>Boehringer Ingelheim, Reims, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Boehringer Ingelheim, Reims</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Champagne-Ardenne</region><settlement type="city">Reims</settlement></placeName></affiliation></author><author><name sortKey="Cescutti, Jessica" sort="Cescutti, Jessica" uniqKey="Cescutti J" first="Jessica" last="Cescutti">Jessica Cescutti</name><affiliation wicri:level="3"><nlm:affiliation>Boehringer Ingelheim, Reims, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Boehringer Ingelheim, Reims</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Champagne-Ardenne</region><settlement type="city">Reims</settlement></placeName></affiliation></author><author><name sortKey="Woerle, Hans Juergen" sort="Woerle, Hans Juergen" uniqKey="Woerle H" first="Hans-Juergen" last="Woerle">Hans-Juergen Woerle</name><affiliation wicri:level="1"><nlm:affiliation>Boehringer Ingelheim, Ingelheim, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Boehringer Ingelheim, Ingelheim</wicri:regionArea><wicri:noRegion>Ingelheim</wicri:noRegion><wicri:noRegion>Ingelheim</wicri:noRegion><wicri:noRegion>Ingelheim</wicri:noRegion></affiliation></author><author><name sortKey="Von Eynatten, Maximilian" sort="Von Eynatten, Maximilian" uniqKey="Von Eynatten M" first="Maximilian" last="Von Eynatten">Maximilian Von Eynatten</name><affiliation wicri:level="1"><nlm:affiliation>Boehringer Ingelheim, Ingelheim, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Boehringer Ingelheim, Ingelheim</wicri:regionArea><wicri:noRegion>Ingelheim</wicri:noRegion><wicri:noRegion>Ingelheim</wicri:noRegion><wicri:noRegion>Ingelheim</wicri:noRegion></affiliation></author></analytic><series><title level="j">Diabetes & vascular disease research</title><idno type="eISSN">1752-8984</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Albuminuria (blood)</term><term>Albuminuria (diet therapy)</term><term>Blood Glucose (drug effects)</term><term>Diabetes Mellitus, Type 2 (complications)</term><term>Diabetes Mellitus, Type 2 (drug therapy)</term><term>Dipeptidyl-Peptidase IV Inhibitors (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Hyperglycemia (drug therapy)</term><term>Hypoglycemic Agents (therapeutic use)</term><term>Kidney Diseases (complications)</term><term>Kidney Diseases (etiology)</term><term>Linagliptin (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Albuminurie (diétothérapie)</term><term>Albuminurie (sang)</term><term>Diabète de type 2 ()</term><term>Diabète de type 2 (traitement médicamenteux)</term><term>Femelle</term><term>Glycémie ()</term><term>Humains</term><term>Hyperglycémie (traitement médicamenteux)</term><term>Hypoglycémiants (usage thérapeutique)</term><term>Inhibiteurs de la dipeptidyl-peptidase IV (usage thérapeutique)</term><term>Jeune adulte</term><term>Linagliptine (usage thérapeutique)</term><term>Maladies du rein ()</term><term>Maladies du rein (étiologie)</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="drug effects" xml:lang="en"><term>Blood Glucose</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Albuminuria</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Diabetes Mellitus, Type 2</term><term>Kidney Diseases</term></keywords><keywords scheme="MESH" qualifier="diet therapy" xml:lang="en"><term>Albuminuria</term></keywords><keywords scheme="MESH" qualifier="diétothérapie" xml:lang="fr"><term>Albuminurie</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Diabetes Mellitus, Type 2</term><term>Hyperglycemia</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Kidney Diseases</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Albuminurie</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Dipeptidyl-Peptidase IV Inhibitors</term><term>Hypoglycemic Agents</term><term>Linagliptin</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Diabète de type 2</term><term>Hyperglycémie</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Hypoglycémiants</term><term>Inhibiteurs de la dipeptidyl-peptidase IV</term><term>Linagliptine</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Maladies du rein</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Diabète de type 2</term><term>Femelle</term><term>Glycémie</term><term>Humains</term><term>Jeune adulte</term><term>Maladies du rein</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects with Renal Disease with LINAgliptin (MARLINA-T2D™), a multicentre, multinational, randomized, double-blind, placebo-controlled, parallel-group, phase 3b clinical trial, aims to further define the potential renal effects of dipeptidyl peptidase-4 inhibition beyond glycaemic control. A total of 350 eligible individuals with inadequately controlled type 2 diabetes and evidence of renal disease are planned to be randomized in a 1:1 ratio to receive either linagliptin 5 mg or placebo in addition to their stable glucose-lowering background therapy for 24 weeks. Two predefined main endpoints will be tested in a hierarchical manner: (1) change from baseline in glycated haemoglobin and (2) time-weighted average of percentage change from baseline in urinary albumin-to-creatinine ratio. Both endpoints are sufficiently powered to test for superiority versus placebo after 24 weeks with α = 0.05. MARLINA-T2D™ is the first of its class to prospectively explore both the glucose- and albuminuria-lowering potential of a dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes and evidence of renal disease.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Autriche</li><li>Finlande</li><li>France</li><li>Japon</li><li>États-Unis</li></country><region><li>Brandebourg</li><li>Californie</li><li>Champagne-Ardenne</li><li>Grand Est</li><li>Nouvelle-Galles du Sud</li><li>Vienne (Autriche)</li></region><settlement><li>Potsdam</li><li>Reims</li><li>Sydney</li><li>Vienne (Autriche)</li></settlement><orgName><li>Université de Potsdam</li><li>Université de Sydney</li></orgName></list><tree><country name="Finlande"><noRegion><name sortKey="Groop, Per Henrik" sort="Groop, Per Henrik" uniqKey="Groop P" first="Per-Henrik" last="Groop">Per-Henrik Groop</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Cooper, Mark E" sort="Cooper, Mark E" uniqKey="Cooper M" first="Mark E" last="Cooper">Mark E. Cooper</name></noRegion><name sortKey="Perkovic, Vlado" sort="Perkovic, Vlado" uniqKey="Perkovic V" first="Vlado" last="Perkovic">Vlado Perkovic</name></country><country name="États-Unis"><region name="Californie"><name sortKey="Sharma, Kumar" sort="Sharma, Kumar" uniqKey="Sharma K" first="Kumar" last="Sharma">Kumar Sharma</name></region></country><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Schernthaner, Guntram" sort="Schernthaner, Guntram" uniqKey="Schernthaner G" first="Guntram" last="Schernthaner">Guntram Schernthaner</name></region></country><country name="Japon"><noRegion><name sortKey="Haneda, Masakazu" sort="Haneda, Masakazu" uniqKey="Haneda M" first="Masakazu" last="Haneda">Masakazu Haneda</name></noRegion></country><country name="Allemagne"><region name="Brandebourg"><name sortKey="Hocher, Berthold" sort="Hocher, Berthold" uniqKey="Hocher B" first="Berthold" last="Hocher">Berthold Hocher</name></region><name sortKey="Von Eynatten, Maximilian" sort="Von Eynatten, Maximilian" uniqKey="Von Eynatten M" first="Maximilian" last="Von Eynatten">Maximilian Von Eynatten</name><name sortKey="Woerle, Hans Juergen" sort="Woerle, Hans Juergen" uniqKey="Woerle H" first="Hans-Juergen" last="Woerle">Hans-Juergen Woerle</name></country><country name="France"><region name="Grand Est"><name sortKey="Gordat, Maud" sort="Gordat, Maud" uniqKey="Gordat M" first="Maud" last="Gordat">Maud Gordat</name></region><name sortKey="Cescutti, Jessica" sort="Cescutti, Jessica" uniqKey="Cescutti J" first="Jessica" last="Cescutti">Jessica Cescutti</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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