Journal article

Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan

Alysha M De Livera, Anne Reutens, Mark Cooper, Merlin Thomas, Karin Jandeleit-Dahm, Jonathan E Shaw, Agus Salim

Trials | BMC | Published : 2020

Abstract

BACKGROUND: The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease. An investigator-initiated, double-blind, randomised, placebo-controlled, multicentre phase 2 clinical trial started recruitment in December 2017, with the aim of evaluating the efficacy and safety of GKT13783, in adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48 weeks. METHODS/DESIGN: The trial is currently recruiting in Australia and New Zealand, with recruitment expected to end ..

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