Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial

Publication date: Available online 9 June 2019Source: The Lancet Diabetes & EndocrinologyAuthor(s): Ofri Mosenzon, Thalia Marie Blicher, Signe Rosenlund, Jan W Eriksson, Simon Heller, Ole Holm Hels, Richard Pratley, Thozhukat Sathyapalan, Cyrus Desouza, R Abramof, D Alpenidze, S Aronoff, K Astamirova, B Barker, G Bedel, L Belousova, M Benson, I Beshay, W Biggs, K BlazeSummaryBackgroundOral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes. Type 2 diabetes is commonly associated with renal impairment, restricting treatment options. We aimed to investigate the efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment.MethodsThis randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries. Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30–59 mL/min per 1·73 m2, and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without metformin for the past 90 days were eligible. Participants were randomly assigned (1:1) by use of an interactive web-response system, with stratification by glucose-lowering medication and renal function, to receive oral semaglutide (dose escalated to 14 mg once daily) or matching placebo for 26 weeks, in addition to background medication. Participants and site staff were masked to assignment. Two effica...
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research