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

作者：Groop Per Henrik^*; Cooper Mark E; Perkovic Vlado; Sharma Kumar; Schernthaner Guntram; Haneda Masakazu; Hocher Berthold; Gordat Maud; Cescutti Jessica; Woerle Hans Juergen; von Eynatten Maximilian

来源：Diabetes and Vascular Disease Research, 2015, 12(6): 455-462.

DOI：10.1177/1479164115579002

• Dipeptidyl peptidase-4 inhibition
• linagliptin
• type 2 diabetes
• chronic kidney disease
• glycaemic control
• albuminuria

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- and albuminuria-lowering potential of a dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes and evidence of renal disease.

• 出版日期2015-11