Third, sitagliptin may not be the best active comparator for this trial because DPP-4 inhibitors have modest glucose-lowering effects and minimal effect on body weight compared with GLP-1RAs. PIONEER 4 was a 52-week, randomised, double-blind, double-dummy, active-controlled, and placebo-controlled phase 3a trial undertaken at 100 trial sites in 12 countries (Croatia, Czech Republic, Germany, Hungary, Japan, Latvia, Poland, Slovakia, South Africa, Ukraine, United Arab Emirates, and the USA). 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.
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.
PIONEER 4 lasted a year and was a double-blinded, double-dummy trial evaluating 14 mg oral semaglutide compared to Victoza 1.8 mg and placebo in 711 people with type 2 diabetes that isn’t properly controlled by metformin, with or without an SGLT-2 inhibitor. 4 However, they are widely used and are well tolerated.
Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus (PIONEER 4) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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 … Other trials within the PIONEER phase 3 program will assess oral semaglutide against other glucose-lowering medications and with flexible dosing of … Related news story: PIONEER 2, PIONEER 4 show benefits of oral semaglutide in type 2 diabetes PIONEER 5: Published Trial population: Patients with type 2 diabetes and an estimated glomerular filtration rate of 30–59 mL/min per 1.73 m², taking metformin, a sulfonylurea, or both, or basal insulin with/without metformin
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