Fiasp® Demonstrated Effective Overall Blood Sugar Reductions in People With Advanced Type 2 Diabetes Uncontrolled on Multiple Daily Injections (Basal-bolus Regimen)

Bagsværd, Denmark (ots/PRNewswire) - 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
(>=10 years of diagnosis) not optimally controlled on their current
basal-bolus regimen, Fiasp® (fast-acting insulin aspart) effectively
reduced overall blood sugar levels (HbA1c), compared with
conventional insulin aspart.1

"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® 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® 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® 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® 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® 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® 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® 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® 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®
compared with conventional insulin aspart.

About Fiasp®

Fiasp® is the only approved, new-generation, ultra-fast acting2-4
mealtime insulin injection. Fiasp® 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® 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® EMA Summary of Product Characteristics. Bagsværd, Denmark:
Novo Nordisk A/S. Last updated: July 2019.

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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 Søndermølle Rendbæk +45 3075 2253 arnd@novonordisk.com

ots Originaltext: Novo Nordisk A/S
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