Novo's oral GLP-1 analog meets primary in Phase IIIa trials compared with approved therapies

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) reported that oral diabetes candidate semaglutide was at least non-inferior to two approved therapies in reducing HbA1c and led to greater body weight reductions than both drugs in a pair of Phase IIIa trials to treat Type II diabetes. The company said it is on track to submit regulatory applications in 2019 for the oral long-acting glucagon-like peptide-1 (GLP-1) analog.

In the double-blind, international Phase IIIa PIONEER 4 trial, once-daily 14 mg oral semaglutide met the primary endpoint of non-inferiority to Novo's injectable diabetes drug Victoza liraglutide in reducing HbA1c from baseline to week 26, irrespective of treatment discontinuation and use of rescue medication. PIONEER 4 enrolled 711 Type II diabetics inadequately controlled on metformin with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor...