(News Bulletin 247) – Novo Nordisk announces that a phase 3b trial of oral semaglutide administered once daily at 25 mg and 50 mg in people with type 2 diabetes requiring treatment intensification has reached its goal primary by demonstrating a statistically significant and greater reduction in HbA1c at week 52 compared to the 14 mg dose of oral semaglutide.
Thus, from an initial mean body weight of 96.4 kg, those treated with oral semaglutide 25 mg and 50 mg experienced statistically significant weight loss of 7.0 kg and 9.2 kg, respectively, compared to a reduction of 4.5 kg with oral semaglutide 14 mg.
In the trial, all doses of oral semaglutide appeared to have a safe and well-tolerated profile, the lab said.
“We are delighted to see the results of this trial providing further evidence of the benefits of oral semaglutide for people with type 2 diabetes,” said Martin Holst Lange, executive vice president of development at Novo Nordisk.
Novo Nordisk expects to file for regulatory approval in the US and EU in 2023.
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