Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, September 17 2019 - 18:15
AsiaNet
Fiasp(R)Demonstrated Effective Overall Blood Sugar Reductions in People With Advanced Type 2 Diabetes Uncontrolled on Multiple Daily Injections (Basal-bolus Regimen)
BAGSVAERD, Denmark, Sept. 17, 2019 /PRNewswire-AsiaNet/ --

    New data presented today at the 55th Annual Meeting of the European 
Association for the Study of Diabetes (EASD) showed that, for people with 
advanced type 2 diabetes (¡Ã10 years of diagnosis) not optimally controlled on 
their current basal-bolus regimen, Fiasp(R) (fast-acting insulin aspart) 
effectively reduced overall blood sugar levels (HbA1c), compared with 
conventional insulin aspart.1

    Logo - https://mma.prnewswire.com/media/482186/Novo_Nordisk_Logo.jpg 

    "As type 2 diabetes progresses, people living with this condition might 
require a mealtime insulin to bring their post-meal blood sugar spikes down. 
Yet, some people might still struggle with blood sugar control even after the 
addition of a mealtime insulin," said Dr Wendy Lane, Mountain Diabetes and 
Endocrine Center, Asheville, North Carolina, USA, and study lead researcher. 
"With its ultra-fast profile of action, Fiasp(R) may be a suitable alternative 
option for people with type 2 diabetes struggling to manage their post-meal 
spikes." 

    In addition to effective overall blood sugar management, people treated 
with Fiasp(R) reported superior reductions in one-hour post-meal blood sugar 
increment, compared to those receiving conventional insulin aspart.1

    "Research has shown that elevated blood sugar levels can lead to severe 
health implications, especially in those who have lived with type 2 diabetes 
for a long time," said Mads Krogsgaard Thomsen, executive vice president and 
chief science officer of Novo Nordisk. "These trial results confirm that 
Fiasp(R) offers superior post-mealtime reductions, compared to conventional 
insulin aspart, which may help more people with type 2 diabetes to achieve 
their intended blood sugar levels."

    Fiasp(R) also demonstrated a statistically significantly lower rate of 
severe or blood sugar-confirmed hypoglycaemia (low blood sugar) than 
conventional insulin aspart. Other adverse event rates were similar between 
Fiasp(R) and conventional insulin aspart.1

    About the trial1
    The onset 9 trial (1,091 people randomised) was a phase 3, multicentre, 
double-blind, treat-to-target trial. It evaluated the efficacy and safety of 
Fiasp(R) compared with conventional insulin aspart, both with insulin degludec, 
with or without metformin, in adults with advanced type 2 diabetes (living with 
type 2 diabetes for 10 years or more), with HbA1c levels ranging from 7% to 
10%, and who have been treated with a basal-bolus insulin regimen for at least 
one year.  

    The findings showed that Fiasp(R) was non-inferior in change from baseline 
in HbA1c (overall blood sugar) after 16 weeks versus conventional insulin 
aspart (estimated treatment difference [ETD] -0.04%). Fiasp(R) was superior to 
conventional insulin aspart in one-hour post-meal blood sugar increment (ETD 
-0.40 mmol/L). The overall rate of treatment-emergent severe or blood 
sugar-confirmed hypoglycaemia was also statistically significantly lower for 
Fiasp(R) compared with conventional insulin aspart.

    About Fiasp(R)
    Fiasp(R) is the only approved, new-generation, ultra-fast acting2-4 
mealtime insulin injection. Fiasp(R) is insulin aspart in an innovative 
formulation, in which two excipients have been added5: Vitamin B3 (niacinamide) 
increases the speed of absorption6, and a naturally occurring amino acid 
(L-arginine) for stability, when compared with the conventional formulation of 
insulin aspart.5 The result is a mealtime insulin that more closely mimics the 
natural physiological insulin response of a person without diabetes after a 
meal, compared with conventional insulin aspart.5

    Fiasp(R) is indicated for the treatment of diabetes in adults, adolescents 
and children aged one year and above.7

    Novo Nordisk is a global healthcare company with more than 95 years of 
innovation and leadership in diabetes care. This heritage has given us 
experience and capabilities that also enable us to help people defeat obesity, 
haemophilia, growth disorders and other serious chronic diseases. Headquartered 
in Denmark, Novo Nordisk employs approximately 41,600 people in 80 countries 
and markets its products in more than 170 countries. For more information, 
visit novonordisk.com [https://www.novonordisk.com/], Facebook 
[http://www.facebook.com/novonordisk], Twitter 
[http://www.twitter.com/novonordisk], LinkedIn 
[http://www.linkedin.com/company/novo-nordisk], YouTube 
[http://www.youtube.com/novonordisk]. 

    References
    1.	Lane W, et al. Efficacy and safety of fast-acting insulin aspart 
compared with insulin aspart, both with insulin degludec with or without 
metformin, in     adults with type 2 diabetes. Poster presentation at the 55th 
Annual Meeting of EASD. 16-20 September 2019; Barcelona, Spain. 
    2.	Cengiz E, et al. Moving toward the ideal insulin for insulin pumps. 
Expert Review of Medical Devices 2016; 13(1):57-69. 
    3.	Heinemann L and Muchmore DB. Ultrafast-acting insulins: state of the 
art. Journal of Diabetes Science and Technology 2012; 6:728-42. 
    4.	Russell-Jones D, et al. Fast-acting insulin aspart improves glycemic 
control in basal-bolus treatment for type 1 diabetes: results of a 26-week 
multicenter, active-controlled, treat-to-target, randomized, parallel-group 
trial (onset 1). Diabetes Care 2017; 40(7):943-50. 
    5.	Heise T, et al. A pooled analysis of clinical pharmacology trials 
investigating the pharmacokinetic and pharmacodynamic characteristics of 
fast-acting insulin aspart in adults with type 1 diabetes. Clinical 
Pharmacokinetics 2017; 56(5):551-9. 
    6.	Kildegaard J, et al. Elucidating the mechanism of absorption of 
fast-acting insulin aspart: the role of niacinamide. Pharmaceutical Research 
2019; 11;36(3):49. 
    7.	Fiasp(R) EMA Summary of Product Characteristics. Bagsv©¡rd, Denmark: 
Novo Nordisk A/S. Last updated: July 2019.


    Further information
    Media:		
    Mette Kruse Danielsen	+45 3079 3883	mkd@novonordisk.com
		
    Investors:		
    Peter Hugreffe Ankersen	+45 3075 9085	phak@novonordisk.com
    Valdemar Borum Svarrer	+45 3079 0301	jvls@novonordisk.com
    Ann Sondermolle Rendb©¡k	+45 3075 2253	arnd@novonordisk.com


    Source: Novo Nordisk