Novo Nordisk Phase 3a oral diabetes med trial hit primary endpoint

Novo Nordisk announced the headline results from Pioneer 2, the second Phase 3a trial with oral semaglutide for treatment of adults with type 2 diabetes. Oral semaglutide is a new GLP-1 analogue taken once daily as a tablet. The 52-week, open label trial investigated the efficacy and safety of 14 mg oral semaglutide compared with 25 mg empagliflozin in 816 people with type 2 diabetes, inadequately controlled on metformin. The confirmatory endpoints were defined after 26 weeks of treatment. The trial achieved its primary objective according to the primary statistical approach by demonstrating a statistically significant and superior improvement in HbA1cwith oral semaglutide compared to empagliflozin at 26 weeks. Difference in weight loss at 26 weeks between oral semaglutide and empagliflozin was not statistically significant when applying the primary statistical approach. When applying the secondary statistical approach, people treated with 14 mg oral semaglutide achieved a statistically significant improvement in HbA1cof 1.4% at 26 weeks and 1.3% at 52 weeks, compared to an improvement in HbA1cof 0.9% and 0.8% with 25 mg empagliflozin at 26 and 52 weeks, respectively. The 14 mg dose of oral semaglutide demonstrated weight loss of 4.2 kg at 26 weeks and 4.7 kg at 52 weeks versus 3.8 kg with 25 mg empagliflozin at both 26 weeks and 52 weeks. The increased weight loss with oral semaglutide was statistically significant compared to empagliflozin at the 52-week time point. In the trial, oral semaglutide was well-tolerated and with a profile consistent with GLP-1-based therapy, Novo said. The most common adverse event for oral semaglutide was mild to moderate nausea, which diminished over time, it added. In Pioneer 2, 20% of people treated with oral semaglutide experienced nausea during the trial. The proportion of subjects who discontinued treatment due to adverse events was 11% for people treated with 14 mg oral semaglutide compared to 4% for people treated with 25 mg empagliflozin

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