BioCentury
ARTICLE | Clinical News

Victoza/Tresiba combo meets diabetes endpoint

December 20, 2012 1:32 AM UTC

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said IDegLira plus metformin met the primary endpoint of reducing HbA1c from baseline to week 26 vs. Tresiba plus metformin in the Phase IIIa DUAL II trial to treat Type II diabetes. IDegLira plus metformin led to a 1.9% reduction in HbA1c from baseline to week 26; baseline HbA1c in the arm was 8.7%. The double-blind, international trial enrolled about 400 Type II diabetics inadequately controlled on basal insulin in combination with one or two oral anti-diabetic agents.

IDegLira is a fixed-dose combination of Novo's Victoza liraglutide, a long-acting analog of glucagon-like peptide-1 (GLP-1), and the company's Tresiba insulin degludec, a long-acting insulin analog. Tresiba is approved in Japan and is under review in the U.S., Europe and Canada. Novo Nordisk said it plans to submit regulatory applications for IDegLira in the U.S. and EU in 2013, pending approval of Tresiba. ...