TY - JOUR
T1 - Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction
T2 - Rationale and design of the MARLINA-T2D™ trial
AU - Groop, Per Henrik
AU - Cooper, Mark E.
AU - Perkovic, Vlado
AU - Sharma, Kumar
AU - Schernthaner, Guntram
AU - Haneda, Masakazu
AU - Hocher, Berthold
AU - Gordat, Maud
AU - Cescutti, Jessica
AU - Woerle, Hans Juergen
AU - Von Eynatten, Maximilian
N1 - Publisher Copyright:
© 2015 The Author(s).
PY - 2015/11/1
Y1 - 2015/11/1
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 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 α = 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.
AB - 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 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 α = 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 - albuminuria
KW - chronic kidney disease
KW - glycaemic control
KW - linagliptin
KW - type 2 diabetes
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U2 - 10.1177/1479164115579002
DO - 10.1177/1479164115579002
M3 - Article
C2 - 26224765
AN - SCOPUS:84945315616
SN - 1479-1641
VL - 12
SP - 455
EP - 462
JO - Diabetes and Vascular Disease Research
JF - Diabetes and Vascular Disease Research
IS - 6
ER -