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.…
MetadatenAuthor details: | 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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Title of parent work (English): | Diabetes & vascular disease research |
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Subtitle (English): | Rationale and design of the MARLINA–T2D TM trial |
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Publication series (Volume number): | Zweitveröffentlichungen der Universität Potsdam : Mathematisch-Naturwissenschaftliche Reihe (419) |
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Publication type: | Postprint |
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Language: | English |
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Date of first publication: | 2018/04/17 |
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Publication year: | 2015 |
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Publishing institution: | Universität Potsdam |
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Release date: | 2018/04/17 |
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Tag: | Dipeptidyl peptidase-4 inhibition; albuminuria; chronic kidney disease; glycaemic control; linagliptin; type 2 diabetes |
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Number of pages: | 8 |
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Source: | Diabetes & Vascular Disease Research 12 (2015) Nr. 6, S. 455–462 DOI: 10.1177/1479164115579002 |
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Organizational units: | Mathematisch-Naturwissenschaftliche Fakultät |
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DDC classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Peer review: | Referiert |
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Publishing method: | Open Access |
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Grantor: | Sage |
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License (German): | Keine öffentliche Lizenz: Unter Urheberrechtsschutz |
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External remark: | Bibliographieeintrag der Originalveröffentlichung/Quelle |
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