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PIONEER 1: Randomized clinical trial of the efficacy and safety of oral semaglutide monotherapy in comparison with placebo in patients with type 2 diabetes

Diabetes Care Jul 25, 2019

Aroda VR, et al. - Via a 26-week, phase 3a, randomized, double-blind, placebo-controlled, parallel-group trial in 93 sites in nine countries with 703 adults with type 2 diabetes not well controlled with diet and exercise, researchers determined the effectiveness and safety of oral semaglutide monotherapy vs placebo in subjects with type 2 diabetes. Oral semaglutide decreased HbA1c. The most prevalent adverse events with oral semaglutide were mild-to-moderate transient gastrointestinal events. In 2.3–7.4% with oral semaglutide and 2.2% with placebo, discontinuations of the trial product were noted. Hence, oral semaglutide monotherapy was superior and clinically improved HbA1c (all doses) and body weight loss (14 mg dose) vs placebo; the safety profile was consistent with other GLP-1 receptor agonists in those with type 2 diabetes.

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