@article{21840,
  author = {Cooper M. and Haneda M. and Groop P. and Woerle H. and von Eynatten M. and Sharma K. and Schernthaner G. and Hocher B. and Gordat M. and Cescutti J. and Perkovic Vlado},
  title = {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},
  abstract = {<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>
},
  year = {2015},
  journal = {Diabetes and Vascular Disease Research},
  volume = {12},
  edition = {2015/08/01},
  number = {6},
  pages = {455-62},
  isbn = {1752-8984 (Electronic)<br/>1479-1641 (Linking)},
  note = {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.},
  language = {eng},
}