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Oral semaglutide vs subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): A randomised, double-blind, phase 3a trial

The Lancet Jul 11, 2019

Pratley R, et al. - Among patients with type 2 diabetes recruited from 100 sites in 12 countries, researchers compared oral semaglutide [a novel glucagon-like peptide-1 (GLP-1) agonist] to subcutaneous liraglutide and placebo. According to the eligibility criteria for inclusion in this study, participants were required to be of 18 years of age or older, with glycated haemoglobin (HbA1c) of 7·0–9·5% (53–80·3 mmol/mol), on a stable dose of metformin (≥1500 mg or maximum tolerated) with or without a sodium-glucose co-transporter-2 inhibitor. In a random manner (2:2:1), once-daily oral semaglutide (dose escalated to 14 mg), once-daily subcutaneous liraglutide (dose escalated to 1·8 mg), or placebo was administered to participants for 52 weeks. As for efficacy in reducing HbA1c, non-inferiority of oral semaglutide to subcutaneous liraglutide and superiority to placebo was evident, and oral semaglutide was found to be superior to both liraglutide and placebo in terms of efficacy in decreasing bodyweight at week 26. Compared to subcutaneous liraglutide, similar safety and tolerability were displayed by oral semaglutide. Earlier start of GLP-1 receptor agonist therapy in the diabetes treatment continuum of care might result from the use of oral semaglutide.

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