01968nas a2200253   4500000000100000008004100001100001400042700001400056700001300070700001400083700002000097700001400117700002000131700001400151700001400165700001600179700001900195245020300214250001500417300001100432490000700443520121300450020005101663       2015                            d1 aCooper M.1 aHaneda M.1 aGroop P.1 aWoerle H.1 avon Eynatten M.1 aSharma K.1 aSchernthaner G.1 aHocher B.1 aGordat M.1 aCescutti J.1 aPerkovic Vlado00aDipeptidyl 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  a2015/08/01  a455-620 v123 a<p>
Efficacy, Safety &amp; 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 alpha = 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.
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