Per-Henrik Groop, Mark E. Cooper, Vlado Perkovic, Kumar Sharma, Guntram Schernthaner, Masakazu Haneda, Berthold Hocher, Maud Gordat, Jessica Cescutti, Hans-Juergen Woerle, Maximilian von Eynatten
- 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 5mg or placebo in addition to their stable glucose-lowering background therapy for 24weeks. 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 24weeks with =0.05. MARLINA-T2D is the first of its class to prospectively explore both the glucose- andEfficacy, 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 5mg or placebo in addition to their stable glucose-lowering background therapy for 24weeks. 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 24weeks with =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.…
MetadatenVerfasserangaben: | Per-Henrik Groop, Mark E. Cooper, Vlado Perkovic, Kumar Sharma, Guntram Schernthaner, Masakazu Haneda, Berthold HocherORCiDGND, Maud Gordat, Jessica Cescutti, Hans-Juergen Woerle, Maximilian von Eynatten |
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DOI: | https://doi.org/10.1177/1479164115579002 |
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ISSN: | 1479-1641 |
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ISSN: | 1752-8984 |
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Pubmed ID: | https://pubmed.ncbi.nlm.nih.gov/26224765 |
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Titel des übergeordneten Werks (Englisch): | Diabetes & vascular disease research : official journal of the International Society of Diabetes and Vascular Disease |
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Verlag: | Sage Publ. |
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Verlagsort: | London |
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Publikationstyp: | Wissenschaftlicher Artikel |
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Sprache: | Englisch |
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Jahr der Erstveröffentlichung: | 2015 |
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Erscheinungsjahr: | 2015 |
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Datum der Freischaltung: | 27.03.2017 |
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Freies Schlagwort / Tag: | Dipeptidyl peptidase-4 inhibition; albuminuria; chronic kidney disease; glycaemic control; linagliptin; type 2 diabetes |
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Band: | 12 |
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Ausgabe: | 6 |
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Seitenanzahl: | 8 |
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Erste Seite: | 455 |
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Letzte Seite: | 462 |
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Fördernde Institution: | Boehringer Ingelheim |
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Organisationseinheiten: | Mathematisch-Naturwissenschaftliche Fakultät / Institut für Ernährungswissenschaft |
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Peer Review: | Referiert |
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Externe Anmerkung: | Zweitveröffentlichung in der Schriftenreihe Postprints der Universität Potsdam : Mathematisch-Naturwissenschaftliche Reihe ; 419 |
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