PIONEER 5: Published PIONEER 2, PIONEER 4 show benefits of oral semaglutide in type 2 diabetes medwireNews : Data from the phase IIIa PIONEER 2 and PIONEER 4 studies show that semaglutide equals or betters both empagliflozin and liraglutide for the reduction of glycated hemoglobin (HbA1c) in patients with type 2 diabetes uncontrolled on metformin. However, semaglutide produced significantly greater weight loss than liraglutide, at an average of 4.4 versus 3.1 kg, and both were better than placebo, at 0.5 kg. PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes. Aroda VR(1)(2), Rosenstock J(3), Terauchi Y(4), Altuntas Y(5), Lalic NM(6), Morales Villegas EC(7), Jeppesen OK(8), Christiansen E(8), Hertz CL(8), Haluzík M; PIONEER 1 Investigators. Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial. Oral Semaglutide Bests Liraglutide in Patients with Type 2 Diabetes. Lancet. Pratley R, Amod A, Hoff ST, Kadowaki T, Lingvay I, Nauck M, Pedersen KB, Saugstrup T, Meier JJ; PIONEER 4 investigators.
PIONEER 4 (NCT02863419), which was simultaneously published in The Lancet, 11 was a comparative study of 14 mg oral semaglutide, liraglutide, the most widely used injectable GLP-1 agonist, and placebo in 711 people with T2D inadequately controlled on metformin, with or without an SGLT-2 inhibitor. The PIONEER phase 3a clinical development programme for oral semaglutide is a global development programme with an expected enrolment of more than 9,000 people with type 2 diabetes … The PIONEER 4 study, 1 of 10 studies in the oral semaglutide phase III program, compared the efficacy and safety of oral semaglutide 14 mg with that of the most widely used GLP-1 … Erratum in: Lancet. In the 52-week, randomized, double-blind trial PIONEER 4, researchers assigned 285 adults to semaglutide, 284 adults to 1.8 mg liraglutide per day and 142 adults to placebo. Epub 2019 Jun 8. Death from any cause occurred in 23 of 1591 patients (1.4%) in the oral semaglutide group and 45 of 1592 (2.8%) in the placebo group (hazard ratio, 0.51; 95% CI, 0.31 to 0.84). Description: The goal of the trial was to assess the safety and efficacy of oral semaglutide compared with subcutaneous liraglutide and placebo among patients with type 2 diabetes. Rodbard HW(1), Rosenstock J(2), Canani LH(3), Deerochanawong C(4), Gumprecht J(5), Lindberg SØ(6), Lingvay I(7), Søndergaard AL(6), Treppendahl MB(6), Montanya E; PIONEER …
2019;394:39-50.
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