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 --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) notoptimally 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 oneyear 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,Facebook,Twitter,LinkedIn,YouTube.

References

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.

Cengiz E,et al. Moving toward the ideal insulin for insulin pumps. Expert Review of Medical Devices 2016; 13(1):57-69.

Heinemann L and Muchmore DB. Ultrafast-acting insulins: state of the art. Journal of Diabetes Science and Technology 2012; 6:728-42.

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.

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.

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.

Fiasp® 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 Søndermølle Rendbaek

+45 3075 2253

arnd@novonordisk.com