Re: Novo Nordisk to Begin Phase 3 Studies of Ultra-Rapid-Acting Version of Novolog i
posted on
Mar 17, 2013 07:35PM
Edit this title from the Fast Facts Section
I think I may be getting confused by the terminology. My understanding is that Novo Nordisk's insulin aspart is marketed as Novolog in the US and NovoRapid in Europe and that FIAsp is a new version that is faster than NovoRapid/Novolog. The monolog seems to be about NovoRapid. This quote"The new formulation of insulin aspart selected for phase 3 development has a faster onset of appearance than NovoRapid® (NovoLog® in the US) and thereby mimics the endogenous insulin secretory response in a non-diabetic individual more closely.", was extracted from the Novo Nordisk's company announcement below.
FIAsp approved for phase 3 development (NN1218)
The phase 1 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 analysed in people with type 1 and type 2 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 3 development has a faster onset of appearance than NovoRapid® (NovoLog® in the US) 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.
In the proof of concept trials, no apparent differences between NovoRapid® and the new formulations of insulin aspart were observed with respect to adverse events and standard safety parameters.
Novo Nordisk expects to initiate the phase 3 programme, onset®, expected to include around 3,000 people with type 1 or type 2 diabetes, towards the end of 2013.