Oral semaglutide shows statistically significantly greater reductions in HbA1c and weight compared to Victoza® and sitagliptin in the PIONEER 4 and 7 trials - Seite 3

In the trial, oral semaglutide was well-tolerated and with a profile consistent with GLP-1-based therapy. The most common adverse event for oral semaglutide was mild to moderate nausea, which diminished over time. In PIONEER 7, 21% of people treated with oral semaglutide experienced nausea, compared to 2% of people treated with sitagliptin. The proportion of people who discontinued treatment due to adverse events was 9% for people treated with oral semaglutide compared to 3% for people treated with sitagliptin.

"With the significant one-year results in a real-world dose setting, oral semaglutide was superior to sitagliptin by documenting a greater proportion of people achieving the ADA target," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "At the same time, we have shown that oral semaglutide is even more efficacious in lowering glucose and body weight than the most widely used injectable GLP-1 treatment, Victoza^®".

About PIONEER 4, PIONEER 7 and the PIONEER clinical trial programme
PIONEER 4 was a 52-week, randomised, double-blinded, double-dummy, active- and placebo-controlled, parallel-group, multicentre, multinational trial with three arms comparing the efficacy and safety of 14 mg oral semaglutide compared to Victoza^® and vs placebo in people with type 2 diabetes, inadequately controlled on metformin with or without a sodium-glucose co-transporter-2 (SGLT-2) inhibitor. PIONEER 4 randomised 711 people in a 2:2:1 manner to receive either 14 mg oral semaglutide, Victoza^® 1.8 mg, or placebo once daily. The primary endpoint was change from baseline to week 26 in HbA_1c. Key secondary endpoints included change in HbA_1c and body weight from baseline to week 52.

PIONEER 7 was a 52-week, randomised, open-label, active-controlled, parallel-group, multicentre, multinational trial with two arms comparing the efficacy and safety of oral semaglutide using a flexible dose adjustment (3, 7 or 14 mg) based on clinical evaluation (glycaemic target and tolerability) of their response to treatment compared with sitagliptin in people with type 2 diabetes mellitus, inadequately controlled on 1-2 oral antidiabetics. PIONEER 7 enrolled 504 people randomised 1:1 to receive either oral semaglutide or 100 mg sitagliptin once daily. The primary endpoint was HbA_1c below 7% as per the ADA treatment target at week 52. Key secondary endpoints included change in HbA_1c and body weight from baseline to week 52.