PIONEER 5: Published

Oral Semaglutide Bests Liraglutide in Patients with Type 2 Diabetes.
The PIONEER 4 trial showed that oral semaglutide is noninferior to injectable liraglutide and superior to placebo in improving glycemic control and weight loss at 26 weeks among patients with type 2 diabetes.

2019 Jul 6;394(10192):39-50. doi: 10.1016/S0140-6736(19)31271-1.

Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes (PIONEER 9) The safety … 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. Lancet.

2019 Jul … Pratley R, Amod A, Hoff ST, Kadowaki T, Lingvay I, Nauck M, Pedersen KB, Saugstrup T, Meier JJ; PIONEER 4 investigators. 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).
RESEARCH DESIGN AND METHODS Patients with type 2 diabetes uncontrolled on insulin with or without metformin were randomized to oral semaglutide … Patients (pts) with T2D uncontrolled on metformin ± SGLT2i were randomized to oral semaglutide (sema) 14 mg once daily (N=285), liraglutide (lira) 1.8 mg (N=284) or placebo (pbo, N=142) in a phase …

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. 2019;394:39-50.

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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. Gastrointestinal adverse events leading to discontinuation of oral semaglutide or placebo were more common with oral semaglutide.

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

OBJECTIVE To investigate the efficacy, safety, and tolerability of oral semaglutide added to insulin with or without metformin. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. 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. Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial. 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. 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 … PIONEER 4 was a 52-week double-blinded, double-dummy trial investigating the efficacy and safety of 14 mg oral semaglutide compared with Victoza ® … 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 … Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial Previous Article Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study Epub 2019 Jun 8. Results of the PIONEER 5 trial, which involved 324 people with T2D and moderate renal impairment, showed that those treated with 14 mg oral semaglutide saw an A1C reduction of 1.1%, …

Lancet. This article reports the results of PIONEER 3, a trial that compared the efficacy, long-term adverse event profile, and tolerability of oral semaglutide with sitagliptin, a widely used DPP-4 inhibitor, as an add …

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 …

Related news story: PIONEER 2, PIONEER 4 show benefits of oral semaglutide in type 2 diabetes. Richard E. Pratley, MD, director of the Florida Hospital Diabetes Institute and professor of medicine at the Sanford Burnham Medical Research Institute in Winter Park, Florida, and colleagues presented findings of the PIONEER 4 …