Novo Nordisk (NYSE:NVO) announces positive results from two Phase 3 clinical trials evaluating its oral semaglutide in adults with type 2 diabetes (T2D). The data were presented at the American Diabetes Association Scientific Sessions in San Francisco.
In PIONEER 2, once-daily 14 mg doses of oral semaglutide demonstrated statistically significantly better HbA1C reduction compared to once-daily 25 mg doses Eli Lilly’s (NYSE:LLY) oral Jardiance (empagliflozin) at week 26 (1.3% vs. 0.9%; p<0.0001). Weight loss at weeks 26 and 52 (3.8 kg at both time points) slightly favored oral semaglutide versus Jardiance (3.7 kg, 3.6 kg) but the separation was not statistically valid.
In PIONEER 4, once-daily doses of 14 mg of oral semaglutide demonstrated a non-inferior (no worse than) reduction in HbA1C compared to once-daily injections of Victoza (liraglutide) at week 26 (1.2% vs. 1.1%) while demonstrating superiority versus placebo (1.2% vs. 0.2%).
At week 52, the HbA1C-lowering effect in the oral semaglutide cohort was statistically significantly better than Victoza and control (1.2% vs. 0.9% and 0.2%, respectively) as was weight loss at weeks 26 (4.4 kg vs. 3.1 kg and 0.5 kg, respectively) and 52 (4.3 kg vs. 3.0 kg and 1.0 kg, respectively).
Previously reported results from another Phase 3, PIONEER 3, showed the superiority of oral semaglutide compared to Merck’s (NYSE:MRK) oral Januvia (sitagliptin).
The company filed its U.S. marketing application in late March with a Priority Review Voucher that cuts the action date to six months after the agency formally accepts it for review.
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