Fiasp(R) Significantly Improved Overall Blood Sugar Control in Type 1 Diabetes Long-term

PR70028

LISBON, Sept. 12 /PRNewswire=KYODO JBN/ -

Fiasp(R)(fast-acting insulin aspart), the only approved, new-generation,

ultra-fast acting[1]-[3] mealtime insulin, improved overall blood sugar (HbA1c)

and post-meal sugar (postprandial glucose or PPG) control over 52 weeks,

compared to conventional insulin aspart (NovoRapid(R), in new study findings[4].

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The findings were presented today at the 53rd European Association for the

Study of Diabetes (EASD) Annual Meeting, and showed that Fiasp(R) maintained

the significant improvement in overall blood sugar control that was seen in a

shorter-term (26 weeks) study period[1]. The results also reconfirmed the

safety profile of Fiasp(R), showing comparable overall numbers of severe or

blood-sugar confirmed hypoglycaemia (low blood sugar levels)[4].

"These results provide reassurance of the meaningful long-term benefits of

Fiasp(R) versus conventional insulin aspart," said Professor Chantal Mathieu,

study investigator, chair of Endocrinology and professor of Medicine at

Katholieke Universiteit Leuven, Belgium. "Accordingly, for people with diabetes

who struggle to control their post-meal sugar levels, Fiasp(R) might offer a

better option to meet their needs."

After eating, blood sugar levels rise rapidly. In diabetes, the body either

cannot bring these high sugar levels down, or struggles to do so. Sustained

high post-meal sugar levels are associated with an increased risk of

cardiovascular disease and other diabetes-related complications, including

damage to eyes and kidneys and cancer[5],[6]. High post-meal sugar levels also

contribute to inadequate overall blood sugar control[2],[5],[7].

While mealtime insulins aim to bring post-meal sugar levels down, conventional

rapid-acting insulins are not as fast as the speed of the natural physiological

insulin response. Due to this slower response, people with diabetes can remain

in an elevated post-meal sugar state for an extended period[2].

"Compared to conventional insulin aspart, Fiasp(R) is a closer match to the

natural physiological insulin response, leading to better long-term blood sugar

control," said Mads Krogsgaard Thomsen, executive vice president and chief

science officer of Novo Nordisk. "Fiasp(R) delivers benefits for people with

diabetes, helping them to achieve better post-meal and overall blood sugar

control."

About the study

The onset 1 trial (1,143 people randomised) was a phase 3a, partially

double-blind, basal-bolus, treat-to-target trial, evaluating the efficacy and

safety of Fiasp(R) compared with conventional insulin aspart in type 1 diabetes

over 52 weeks, in two 26 week treatment periods. The findings from the 52 week

study period were presented at the EASD Annual Meeting 2017.

In the 52 week study period, Fiasp(R)demonstrated a statistically significantly

greater overall blood sugar reduction of -0.10% in adults with type 1 diabetes,

in comparison to conventional insulin aspart. Fiasp(R) also showed a

statistically significant reduction in 1-hour post-meal sugar increment of

-0.91 mmol/L; no significant difference was seen in 2-hour post-meal sugar

increment, compared with conventional insulin aspart. These results were

achieved with a comparable overall rate of severe or blood-sugar confirmed

hypoglycaemia between the two treatments[4].

About Fiasp(R)

Fiasp(R)is the only approved, new-generation, ultra-fast acting[1]-[3] mealtime

insulin. Fiasp(R) is insulin aspart in an innovative formulation, in which two

excipients have been added: Vitamin B3 (niacinamide) to increase the speed of

absorption and a naturally occurring amino acid (L-Arginine) for stability[8].

Fiasp(R) received marketing authorisation from the European Commission on 9

January, from Health Canada on 6 January, from Swissmedic on 7 June and from

the Australian Government Department of Health on 28 June 2017. It is currently

under regulatory review in over 10 countries.

After receiving a Complete Response Letter (CRL) from the US Food and Drug

Administration (FDA) in October 2016, Novo Nordisk resubmitted the fast-acting

insulin aspart new drug application (NDA) as a class II resubmission on 29

March 2017 and FDA approval is expected at the end of Q3 2017.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of

innovation and leadership in diabetes care. This heritage has given us

experience and capabilities that also enable us to help people defeat other

serious chronic conditions: haemophilia, growth disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 41,400 people in

77 countries and markets its products in more than 165 countries. For more

information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube

References

1. 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.

2. Heinemann L and Muchmore DB. Ultrafast-acting insulins: state of the art.

Journal of Diabetes Science and Technology 2012; 6(4):728-42.

3. Cengiz E, et al. Moving toward the ideal insulin for insulin pumps. Expert

Review of Medical Devices 2016; 13(1):57-69.

4. Mathieu C, et al. Efficacy and safety of fast-acting insulin aspart are

maintained over 52 weeks: comparison with insulin aspart in onset 1. Poster

presentation at the 53rd EASD Annual Meeting. 11-15 September 2017; Lisbon,

Portugal.

5. Madsbad S. Impact of postprandial glucose control on diabetes-related

complications: how is the evidence evolving? Journal of Diabetes and Its

Complications 2016; 30(2):374-85.

6. International Diabetes Federation (IDF). Guideline for management of

postmeal glucose in diabetes. 2011.

7. Monnier L, et al. Postprandial and basal glucose in type 2 diabetes:

assessment and respective impacts. Diabetes Technology & Therapeutics 2011;

13(Suppl.1):25-32.

8. 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.

Further information

Media:        

Katrine Sperling

+45-3079-6718    

krsp@novonordisk.com

Åsa Josefsson

+45-3079-7708

aajf@novonordisk.com

Investors:        

Peter Hugreffe Ankersen  

+45-3075-9085

phak@novonordisk.com

Hanna Ögren

+45-3079-8519

haoe@novonordisk.com

Anders Mikkelsen

+45-3079-4461  

arm@novonordisk.com

Christina Jensen

+45-3079-3009  

cnje@novonordisk.com

Kasper Veje (US)

+1-609-235-8567  

kpvj@novonordisk.com  

ZINC#: HQMMA/FA/0717/0218

Date of preparation: August 2017

SOURCE: Novo Nordisk