Oral semaglutide 7 and 14 mg once daily significantly reduced glycated haemoglobin () and body weight in patients with type 2 diabetes over treatment periods of up to 78 weeks.
Oral semaglutide was tested in patients with type 2 diabetes with a duration of 3.5 to 15 years.
The treatment showed better efficacy than placebo and standard glucose-lowering medications, including sitagliptin and empagliflozin.
Patients experienced improvements in other diabetes-related endpoints, such as fasting plasma glucose.
Oral semaglutide was well tolerated, with transient gastrointestinal events being the most common side effects.
Cardiovascular safety was confirmed for oral semaglutide in patients with cardiovascular disease or high cardiovascular risk.
Simplified
Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are recommended for glycaemic management in patients with type 2 diabetes (T2D). Oral semaglutide, the first oral GLP-1RA, has recently been approved for clinical use, based on the results of the randomized, Phase 3a Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) clinical trials. The PIONEER programme tested oral semaglutide in patients with T2D of duration ranging from 3.5 to 15 years, from monotherapy through to insulin add-on, in global populations and two trials dedicated to Japanese patients. Outcomes (glycated haemoglobin [] and body weight reduction, plus other relevant efficacy and safety endpoints) were tested against both placebo and active standard-of-care medications. A separate trial evaluated the cardiovascular safety of oral semaglutide in patients with T2D at high cardiovascular risk. Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA1c and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose. Oral semaglutide provided significantly better efficacy than placebo and commonly used glucose-lowering medications from the dipeptidyl peptidase-4 inhibitor (sitagliptin) and sodium-glucose co-transporter-2 inhibitor (empagliflozin) classes, as well as the subcutaneous GLP-1RAs liraglutide and dulaglutide. Oral semaglutide was well tolerated in line with the known safety profile of GLP-1RAs, with transient gastrointestinal events being the most common side effects reported. Cardiovascular safety was demonstrated for oral semaglutide in patients with cardiovascular disease or high cardiovascular risk. The results of the PIONEER programme suggest that oral semaglutide is efficacious and well tolerated for glycaemic control of T2D. The availability of oral semaglutide may help to broaden treatment choice and facilitate adoption of earlier GLP-1RA treatment in the paradigm of T2D management.
Key numbers
−1.0%
Reduction
Change in for oral semaglutide vs. placebo in PIONEER 6.
−4.2 kg
Weight Loss
Mean weight reduction with oral semaglutide vs. placebo in patients with cardiovascular disease.
80%
Trial Completion Rate
Percentage of patients completing the PIONEER trials.
Full Text
We can’t show the full text here under this license.
T.K.T. is on the speaker's bureau for Novo Nordisk and is one of the US national leads for the Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes (SOUL) trial (NCT03914326). R.P. has received lecture and consulting fees from AstraZeneca; consulting fees from Boehringer Ingelheim, Eisai, GlaxoSmithKline and Mundipharma; grants and lecture/consulting fees from Glytec, Janssen, Novo Nordisk, Pfizer and Takeda; grants from Lexicon Pharmaceuticals; and grants and consulting fees from Ligand Pharmaceuticals, Lilly, Merck and Sanofi‐Aventis US. Except for consulting fees in February 2018 and June 2018 received from Sanofi US Services, all fees for services were paid directly to AdventHealth, a non‐profit organization. J.J.M. has received lecture honoraria and consulting fees from AstraZeneca, Berlin‐Chemie, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme (MSD), Novo Nordisk, Novartis and Sanofi; has received reimbursement of congress participation fees and travel expenses from MSD, Novo Nordisk and Sanofi; and has initiated projects supported by Boehringer Ingelheim, MSD, Novo Nordisk and Sanofi.
