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

PR80574

BAGSVAERD, Denmark, Sept. 17, 2019 /PRNewswire=KYODO JBN/ --

    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 (greater-than or equal to 10 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)

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    "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 trial(1)

    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 added(5): Vitamin B3 (niacinamide)

increases the speed of absorption(6), 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. Bagsvaerd, 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 Rendbaek +45 3075 2253 arnd@novonordisk.com

    Source: Novo Nordisk