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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URN: | urn:nbn:de:kobv:517-opus4-404460 |
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Titel des übergeordneten Werks (Englisch): | Diabetes & vascular disease research |
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Untertitel (Englisch): | Rationale and design of the MARLINA–T2D TM trial |
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Schriftenreihe (Bandnummer): | Zweitveröffentlichungen der Universität Potsdam : Mathematisch-Naturwissenschaftliche Reihe (419) |
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Publikationstyp: | Postprint |
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Sprache: | Englisch |
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Datum der Erstveröffentlichung: | 17.04.2018 |
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Erscheinungsjahr: | 2015 |
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Veröffentlichende Institution: | Universität Potsdam |
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Datum der Freischaltung: | 17.04.2018 |
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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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Seitenanzahl: | 8 |
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Quelle: | Diabetes & Vascular Disease Research 12 (2015) Nr. 6, S. 455–462 DOI: 10.1177/1479164115579002 |
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Organisationseinheiten: | Mathematisch-Naturwissenschaftliche Fakultät |
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DDC-Klassifikation: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Peer Review: | Referiert |
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Publikationsweg: | Open Access |
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Fördermittelquelle: | Sage |
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Lizenz (Deutsch): | Keine öffentliche Lizenz: Unter Urheberrechtsschutz |
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Externe Anmerkung: | Bibliographieeintrag der Originalveröffentlichung/Quelle |
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