Compared with placebo, oral semaglutide monotherapy is associated with superior and clinically relevant improvements in glycated hemoglobin (HbA1c) and weight loss among patients with type 2 diabetes, according to a study published online in Diabetes Care.

In a phase 3a, randomized, double-blind, placebo-controlled, parallel-group trial, Vanita R. Aroda, M.D., from Brigham and Women's Hospital in Boston, and colleagues evaluated the safety and efficacy of oral semaglutide, the first oral glucagon-like peptide 1 receptor agonist, as monotherapy in patients with type 2 diabetes managed by diet and exercise alone. The authors randomly assigned (1:1:1:1) 703 patients at 93 international sites to either once-daily oral semaglutide 3 mg, 7 mg, 14 mg, or placebo.

Over 26 weeks, the researchers found that oral semaglutide reduced HbA1c as well as body weight. The most common adverse events associated with oral semaglutide included mild-to-moderate transient gastrointestinal events. Discontinuation of the trial product occurred in 2.3 to 7.4 percent taking oral semaglutide and 2.2 percent among those taking placebo.

"Ongoing additional studies in the PIONEER [Peptide Innovation for Early Diabetes Treatment] program will further define its effect when used in combination with other glucose-lowering therapies and in other populations (e.g., in those with high cardiovascular risk or renal impairment) of interest," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Novo Nordisk, which manufactures semaglutide and funded the study.

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