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Novo Nordisk A/S Announces Final Phase 3a Trial for IDegLira Completed; FIAsp Approved for Phase 3 Development


Wednesday, 19 Dec 2012 10:26am EST 

Novo Nordisk A/S announced the completion of the phase three a (3a) program for IDegLira, a fixed-ratio combination of insulin degludec (Tresiba), a once-daily new-generation basal insulin analog, with an ultralong duration of action, and liraglutide (Victoza), the once-daily human GLP-1 analog, as well as the decision to initiate phase three development for FIAsp, a faster-acting formulation of insulin aspart (NovoRapid). Furthermore, within the biopharmaceutical therapy area it has been decided to discontinue further development of anti-NKG2D as a treatment for Crohn’s disease. DUAL II, the second and final phase 3a trial with IDegLira for the treatment of patients with type two diabetes, has been completed. The phase one proof-of-concept trials for FIAsp have now been completed. In these, the pharmacokinetic and pharmacodynamic properties of insulin aspart in a number of different formulations have been analyzed in people with type one and type two diabetes, in order to identify the formulation with the most attractive profile with regard to speed of onset of appearance, as well as stability. The new formulation of insulin aspart selected for phase three development has a faster onset of appearance than NovoRapid and thereby mimics the endogenous insulin secretory response in a non-diabetic individual more closely. This potentially enables more flexible insulin administration in connection with meals, as well as improved post-prandial glucose control. 

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