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ARTICLE | Clinical News

Novo's oral GLP-1 analog meets in first Phase IIIa for Type II diabetes

February 23, 2018 3:22 PM UTC

Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) said oral semaglutide met the primary endpoint in the Phase IIIa PIONEER 1 trial to treat Type II diabetes. The candidate is on track to be the first approved oral version of a glucagon-like peptide-1 (GLP-1) analog. Novo said it plans to submit a regulatory application for the product next year, but declined to disclose details.

On the 703-patient trial's primary endpoint, once-daily 3, 7 and 14 mg doses of oral semaglutide all significantly improved HbA1c from baseline to week 26 vs. placebo, irrespective of treatment adherence or initiation of rescue medication. Novo said “recent regulatory guidelines” required that the primary endpoint analysis disregard treatment adherence. High-dose oral semaglutide also significantly improved weight loss vs. placebo...