What is it about?
This was the first large phase 3 clinical study to test how effective oral semaglutide, the first oral glucagon-like peptide-1 receptor agonist (GLP-1RA), would be for controlling high blood glucose in patients with type 2 diabetes who were currently managing their disease with just lifestyle changes. Over 26 weeks, oral semaglutide 14 mg (the maximum dose studied) reduced HbA1c (a marker of elevated blood glucose) by 1.4% from a baseline value of 8%, compared to a 0.3% reduction with placebo. Oral semaglutide 14 mg enabled 77% of patients to achieve a diabetes target HbA1c of <7%. Furthermore, patients who were taking oral semaglutide 14 mg also lost body weight (2.3 kg more than with placebo). There were no unexpected safety concerns with oral semaglutide. Some patients did experience mild to moderate gastrointestinal effects, such as nausea, that faded with time, and this is consistent with the known tolerability profile of GLP-1RAs.
Why is it important?
Oral semaglutide is an innovative treatment for type 2 diabetes. Semaglutide belongs to a group of drugs called GLP-1RAs, which are considered a highly effective treatment class. Although GLP-1RAs have been available since 2005, this is the first time a GLP-1RA has been made into a tablet instead of being given by an injection. As such, this treatment increases the oral treatment options for patients with type 2 diabetes who need more effective control of their blood glucose while supporting weight loss.
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This page is a summary of: 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, June 2019, American Diabetes Association, DOI: 10.2337/dc19-0749.
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