TY  - JOUR
A1  - Groop, Per-Henrik
A1  - Cooper, Mark E.
A1  - Perkovic, Vlado
A1  - Sharma, Kumar
A1  - Schernthaner, Guntram
A1  - Haneda, Masakazu
A1  - Hocher, Berthold
A1  - Gordat, Maud
A1  - Cescutti, Jessica
A1  - Woerle, Hans-Juergen
A1  - von Eynatten, Maximilian
T1  - 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
JF  - Diabetes & vascular disease research : official journal of the International Society of Diabetes and Vascular Disease
N2  - 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.
KW  - Dipeptidyl peptidase-4 inhibition
KW  - linagliptin
KW  - type 2 diabetes
KW  - chronic kidney disease
KW  - glycaemic control
KW  - albuminuria
Y1  - 2015
U6  - https://doi.org/10.1177/1479164115579002
SN  - 1479-1641
SN  - 1752-8984
VL  - 12
IS  - 6
SP  - 455
EP  - 462
PB  - Sage Publ.
CY  - London
ER  -