Treatment with oral semaglutide 14 mg led to a statistically significant improvement in hemoglobin A1c (HbA1c) levels and weight loss in adults with type 2 diabetes (T2D) not well controlled with metformin, according to a press release from Novo Nordisk.

In the 52-week open-label PIONEER 2 trial, researchers compared oral semaglutide 14 mg with empagliflozin 25 mg in 816 participants with T2D. 

Participants treated with oral semaglutide 14 mg saw an improvement in HbA1c of 1.4% at 26 weeks and 1.3% at 52 weeks, compared with 0.9% and 0.8% with empagliflozin 25 mg at 26 and 52 weeks, respectively. The American Diabetes Association treatment target of HbA1c <7% was achieved by 72% of the participants taking oral semaglutide compared with 47% of the participants taking empagliflozin at 52 weeks. 

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Oral semaglutide was also associated with a weight loss of 4.2 kg at 26 weeks and 4.7 kg at 52 weeks compared with a weight loss of 3.8 kg with empagliflozin 25 mg at both 26 and 52 weeks.

The most common adverse event in the semaglutide group was mild to moderate nausea, which was experienced by 20% of participants. Overall, 11% of patients in the semaglutide group discontinued treatment due to adverse events compared with 4% in the empagliflozin group. 

“We are very excited about these results, which demonstrate that people treated with 14 mg oral semaglutide for one year achieved statistically significant reductions in blood glucose and body weight compared to people treated with 25 mg empagliflozin,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

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Oral semaglutide shows superior improvement in HbA1c vs empagliflozin in the PIONEER 2 trial [press release]. Novo Nordisk; Bagsværd, Denmark: May 29, 2019. Accessed May 31, 2018.