Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
On June 27, 2023, we reported on a study presented at the 83rd Scientific Sessions of the American Diabetes Association.
The PIONEER PLUS clinical trial is a randomized, multicenter, double-blind, global phase 3b clinical trial to evaluate the efficacy, safety, and tolerability of once-daily oral semaglutide 25 mg and 50 mg compared with the FDA-approved 14 mg dose in adults with inadequately controlled type 2 diabetes (T2D).
Researchers enrolled adults aged ≥18 years and older with T2D, an HbA1c between 8% and 10.5%, and a body mass index of ≥ 25 kg/m2 who were on a stable daily dose of 1 to 3 of the following oral glucose-lowering therapies: metformin, sulfonylurea, SGLT2 inhibitor, or DPP-4 inhibitor.
Participants were randomly assigned, 1:1:1, to oral semaglutide 14 mg, 25 mg, or 50 mg for 68 weeks. Adults continued their existing glucose-lowering medication, except for those receiving DPP-4 inhibitors, who were asked to discontinue the therapy.
A total of 1606 participants (mean age, 58 years; 58.3% men) were enrolled in the study, of whom 536 received oral semaglutide 14 mg, 535 received 25 mg, and 535 received 50 mg.
Researchers found that oral semaglutide 25 mg and 50 mg were superior to 14 mg in reducing HbA1c and bodyweight in adults with inadequately controlled T2D.
A note from authors
"The superior glycemic control and body weight loss with oral semaglutide 25 mg and 50 mg compared with the current highest approved dose of 14 mg observed in PIONEER PLUS suggest that these higher doses might support individually tailored treatment goals, based not only on glucose-lowering but also bodyweight and cardiovascular risk factor reduction targets."