1. 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.
- Author
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Groop PH, Cooper ME, Perkovic V, Sharma K, Schernthaner G, Haneda M, Hocher B, Gordat M, Cescutti J, Woerle HJ, and von Eynatten M
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Albuminuria blood, Diabetes Mellitus, Type 2 complications, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome, Young Adult, Albuminuria diet therapy, Blood Glucose drug effects, Diabetes Mellitus, Type 2 drug therapy, Dipeptidyl-Peptidase IV Inhibitors therapeutic use, Hyperglycemia drug therapy, Hypoglycemic Agents therapeutic use, Kidney Diseases complications, Kidney Diseases etiology, Linagliptin therapeutic use
- Abstract
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., (© The Author(s) 2015.)
- Published
- 2015
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