TY - JOUR
AU - Cooper M.
AU - Haneda M.
AU - Groop P.
AU - Woerle H.
AU - von Eynatten M.
AU - Sharma K.
AU - Schernthaner G.
AU - Hocher B.
AU - Gordat M.
AU - Cescutti J.
AU - Perkovic Vlado
AB - <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.
</p>

AD - Folkhalsan Institute of Genetics, Folkhalsan Research Center, Biomedicum Helsinki, Helsinki, Finland Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland Baker IDI Heart & Diabetes Institute, Melbourne, VIC, Australia per-henrik.groop@helsinki.fi.<br/>Baker IDI Heart & Diabetes Institute, Melbourne, VIC, Australia.<br/>The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.<br/>Research Service and Division of Nephrology-Hypertension, Veterans Affairs San Diego Healthcare System, Veterans Medical Research Foundation, San Diego, CA, USA Center for Renal Translational Medicine, Department of Medicine, University of California, San Diego, La Jolla, CA, USA.<br/>Department of Internal Medicine, Rudolfstiftung Hospital, Vienna, Austria.<br/>Division of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.<br/>Institute of Nutritional Science, University of Potsdam, Potsdam, Germany.<br/>Boehringer Ingelheim, Reims, France.<br/>Boehringer Ingelheim, Ingelheim, Germany.
AN - 26224765
BT - Diabetes and Vascular Disease Research
DP - NLM
ET - 2015/08/01
LA - eng
LB - AUS<br/>R&M<br/>FY16
M1 - 6
N1 - Groop, Per-Henrik<br/>Cooper, Mark E<br/>Perkovic, Vlado<br/>Sharma, Kumar<br/>Schernthaner, Guntram<br/>Haneda, Masakazu<br/>Hocher, Berthold<br/>Gordat, Maud<br/>Cescutti, Jessica<br/>Woerle, Hans-Juergen<br/>von Eynatten, Maximilian<br/>England<br/>Diab Vasc Dis Res. 2015 Nov;12(6):455-62. doi: 10.1177/1479164115579002. Epub 2015 Jul 28.
N2 - <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.
</p>

PY - 2015
SN - 1752-8984 (Electronic)<br/>1479-1641 (Linking)
SP - 455
EP - 62
T2 - Diabetes and Vascular Disease Research
TI - 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
VL - 12
Y2 - FY16
ER -